Page of HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Protocol Deviation Tracking Log Does the Deviation Deviation Impact Affect Affect Subject’s Deviation of Subject ID Deviation Subject Data Willingness to Category Number Initials Initials # Date End Date Deviation Description Safety* Integrity* participate?* Date PI PI (see below) (if applicable) Yes Yes Yes __ / __ / ____ No No No Not Applicable N/A N/A N/A Yes Yes Yes __ / __ / ____ No No No Not Applicable N/A N/A N/A Yes Yes Yes __ / __ / ____ No No No Not Applicable N/A N/A N/A Yes Yes Yes __ / __ / ____ No No No Not Applicable N/A N/A N/A Yes Yes Yes __ / __ / ____ No No No Not Applicable N/A N/A N/A *If one or more is answered yes for any deviation, it must be reported to the IRB promptly (14 business days from notification of or becoming aware of the event). Please refer to the HSIRB Reportable Event guidance for additional information (). Deviation Category: Consent Deviation Drug/Device Administration/Accountability Enrollment Deviation Procedural Deviation Other (describe)
HEADER: PI NAME, Protocol or IRB Number, Protocol Short Title Page of Protocol Deviation Tracking Log # Subject ID Number (if applicable) Deviation Date Deviation End Date Deviation Description Deviation Category (see below) Does the Deviation PI Initials Date of PI Initials Impact Subject Safety* Affect Data Integrity* Affect Subject’s Willingness to participate?* Yes No N/A Yes No N/A Yes No N/A __ / __ / ____ Not Applicable Yes No N/A Yes No N/A Yes No N/A __ / __ / ____ Not Applicable Yes No N/A Yes No N/A Yes No N/A __ / __ / ____ Not Applicable Yes No N/A Yes No N/A Yes No N/A __ / __ / ____ Not Applicable Yes No N/A Yes No N/A Yes No N/A __ / __ / ____ Not Applicable *If one or more is answered yes for any deviation, it must be reported to the IRB promptly (14 business days from notification of or becoming aware of the event). Please refer to the HSIRB Reportable Event guidance for additional information (). Deviation Category: Consent Deviation Drug/Device Administration/Accountability Enrollment Deviation Procedural Deviation Other (describe)
DeviationTrackingLog_Protocol_2018.06.01.docx