Final answer:
If PI Oversight is not compliant, the appropriate steps to be taken may vary depending on the specific situation. However, a general course of action would typically involve reporting the non-compliance to the relevant parties, such as the FDA and the sponsor. Corrective actions should also be taken.
Step-by-step explanation:
If PI Oversight is not compliant, the appropriate steps to be taken may vary depending on the specific situation. However, a general course of action would typically involve reporting the non-compliance to the relevant parties. This could include reporting to the FDA, notifying the sponsor, and taking corrective actions to address the non-compliance.
Reporting to the FDA is important because they are responsible for regulatory oversight of pharmaceuticals and medical devices. If the non-compliance relates to regulatory requirements, it is necessary to inform the FDA so that appropriate actions can be taken.
Notifying the sponsor is also crucial as they may have obligations and responsibilities in overseeing the conduct of the study and ensuring compliance. They can guide and support the necessary corrective actions to address the non-compliance.