During review of monitoring reports for the last year, it was noted that numerous deviations are not being entered into OnCore. This must be completed for all studies to allow the Data and Safety Monitoring Committee to assess your study. Additionally it appears many deviations that were identified are not being reported during continuing reviews to the IRB.
This is something that will be reviewed going forward during review of outside monitoring reports and internal QA monitoring and will become a finding for your study presented to the DSMC. Please ensure patient charts are being reviewed frequently after visits to ensure deviations from the approved protocol are being noted and captured in OnCore in a timely manner. When entering a deviation into OnCore please ensure the information is full and complete so that someone not directly working with your study would understand exactly what occurred.
A deviation is defined as any occurrence happening during a clinical trial that does not occur per the IRB approved protocol. It is important to remember deviations happen! Prompt review and reporting are an important check and balance in clinical research and consistent reviews help to recognize trends so we can try to fix any issues and prevent future deviations.
If you have any questions or would like assistance identifying if something is a deviation, please contact the CCTO Quality Assurance department, firstname.lastname@example.org or stop by our desks on the 3rd floor by the SRC office, and we will be happy to assist!