We have an obligation when submitting for protocol renewal to include information about any noncompliance that has occurred over the last year of research conduct. This includes regulatory noncompliance and deviations.

This is essential for the accountability, correction of non-compliance, prevention of reoccurrences, adherence to the ethical standards, and integrity of the clinical trial.

In eProtocol, where to enter noncompliance in the Continuing Review/Renewal submission?

Helpful Tip! Use OnCore as your deviation log to document ALL protocol deviations. When entered into OnCore you are able to run a PDF report of your study’s deviations that can be attached to the IRB renewal submission! Ensure you specify in 2g what section the PDF is attached.

If you have any questions or concerns, please email dsmc-quality@stanford.edu.

References: HRPP Policy Manual