It is the obligation of the Principal Investigator and their research staff to follow the REB approved protocol ICH E.6 (Section 4.5). However, there are circumstances where a deviation from the protocol occurs. Unfortunately there are no reporting standards for the Investigator to report all protocol deviations to the sponsor or REB. If the protocol deviation is required to ensure participant safety, then the investigator MUST report to the REB. It is the obligation of the Investigator and their staff to document all protocol deviations. The study sponsor and their on site staff will review all protocol deviations and categorize them as per their internal processes.
Canadian SHIELD Ethics Review Board requires that all investigators report the following deviations within 15 days:
• Changes in procedures initiated to ensure participant safety, (24 hours if emergency)
• Enrolment of participants outside protocol inclusion/exclusion criteria, whether agreed to or not by study sponsor,
• Significant deviation in timing or specific study procedures,
• Medication errors
If you have any concerns about a particular protocol deviation and its reportability, please contact CSERB or (905) 681 8661.