Deviations as defined in the NIH Policy 801 Reporting Research Events as any change, divergence, or departure from the IRB-approved research protocol .Protocol deviations have the potential to place participants at risk and can also undermine the scientific integrity of the study, thus jeopardizing the justification for the research. Since July 2019, the Office of Education and Compliance has been tracking deviations as part of the quality management and improvement process. Starting June 2021, deviations are tracked in the Protocol Deviation Tracking System(PDTS) which also allows for easier reporting of deviations for a protocol’s progress report/continuing review. Below are summaries of deviations. Any questions, please contact the Office of Education and Compliance.
Deviation Tracking Summaries
Below are annual deviation summaries.