Protocol Deviation Tracking Log IRB Study # Site Name/Number: Protocol Title Protocol (Abbreviated): ID/Number: Principal Investigator: Page number [1]: Meets IRB Dev. Did Subject IRB Ref Subject Date of Date Reporting Deviation Description Type Continue in Reporting No. ID Deviation Identified in AE? Req. (I.e. NSI) [2] Study? Date (Yes/No) 1 2 3 4 5 6 7
Protocol Deviation Tracking Log IRB Study # Site Name/Number: Protocol Title (Abbreviated): Protocol ID/Number: Principal Investigator: Page number [1]: Ref No. Subject ID Date of Deviation Date Identified Deviation Description Dev. Type [2] in AE? Did Subject Continue in Study? Meets IRB Reporting Req. (I.e. NSI) (Yes/No) IRB Reporting Date 1 2 3 4 5 6 7
Protocol-Deviation-Tracking-Log.docx