Description of Corrective Action: SPONSOR NOTIFICATION: Has the sponsor been notified of this deviation? Yes No N/A If or please explain: “No” “N/A”, SIGN-OFF (not required for within IRISS) Person Completing Form Name: E-mail: Date: Principal Investigator Name (printed): Signature: E-mail: Date: CHAIR/DESIGNATE USE ONLY No further action required Comments/Concerns: Request more information Committee discussion required Signature: Date of Review:
Description of Corrective Action: SPONSOR NOTIFICATION: Has the sponsor been notified of this deviation? Yes No N/A If “No” or “N/A”, please explain: SIGN-OFF (not required for within IRISS) Person Completing Form Name: E-mail: Date: Principal Investigator Signature: Name (printed): E-mail: Date: CHAIR/DESIGNATE USE ONLY No further action required Request more information Committee discussion required Comments/Concerns: Signature: Date of Review:
HREBA-Protocol-Deviation-Form-V1.docx