Deviations and Non-Compliance Handling

This course provides a review of the different types of deviations in regard to patient safety and clinical investigation outcomes. It includes an overview of the necessary steps to correct deviations early-on and to ensure subject safety and data quality. It also gives a general outline of deviation reporting requirements.
The course also covers on what to do if a site is non-compliant with the study requirements and not necessarily related to subject’s participation and points to risk management section of the monitoring plan.