Protocol Deviations and Privacy Breach Reporting

Protocol Deviation Reporting Requirements (pdf)       

 Protocol Deviation Reporting  

As per ICH GCP 4.5.2 "The investigator should not implement any deviation from, or changes of the protocol without agreement by the sponsor and prior review and documented approval/favourable opinion from the IRB/IEC of an amendment, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the change(s) involves only logistical or administrative aspects of the trial (e.g. change in monitor(s), change of telephone number(s).

A protocol deviation is defined any action or inaction that does not correspond to the approved protocol. A protocol deviation may include accidental/unintentional or intentional changes, including changes made to eliminate an immediate hazard to participants or others. Protocol deviations may be major or minor and serious or not serious. All protocol deviations (both minor and major) for all research projects  (i.e. clinical trials, observational studies, retrospective records review, registries, biobanks, etc.) that had not received prior approval by a Bannatyne Campus Research Ethics Board through an amendment, must be reported to the Bannatyne Campus REB office as per  the above guideline.  

As we develop more detailed requirements for reporting privacy breaches/confidentiality breaches please report such as a protocol deviation on the Major Protocol Deviation Form.