PROTOCOL DEVIATION TRACKING LOG Principal Investigator: Site #: IRB#: Protocol #: Study Title: Sponsor: Subject Date of Date Known Description of Deviation/Exception Major/ Subject Action Date PI Comments Date of Sponsor Date of IRB Acknowledgement Notification/ ID Deviation to Minor Harmed Taken/CAPA Sponsored Signature/ Submission Investigator Notified Date 1 2 3 4 5 6
PROTOCOL DEVIATION TRACKING LOG Principal Investigator: Site #: IRB#: Protocol #: Study Title: Sponsor: Subject ID Date of Deviation Date Known to Investigator Description of Deviation/Exception Major/ Minor Subject Harmed Action Taken/CAPA Date Sponsored Notified Date of Sponsor Acknowledgement Date of IRB Notification/ Submission PI Signature/ Date Comments 1 2 3 4 5 6
Protocol_deviation_log.docx