Which resources are MOST relevant for developing and updating a research compliance work plan?

The most relevant resources for developing and updating a research compliance work plan include FDA warning letters, OIG inspection reports, and OHRP determination letters.

FDA warning letters are critical as they provide insights into regulatory enforcement actions taken against entities that do not comply with FDA regulations. These letters often detail violations related to clinical trials and research practices, highlighting areas that might need improvement or further scrutiny within a research compliance framework.

OIG inspection reports are instrumental in understanding compliance with the applicable regulations and policies set forth by the Office of Inspector General. These reports can serve as direct reflections of compliance postures within organizations and shed light on systemic issues that need addressing to enhance compliance in research environments.

OHRP determination letters are specifically relevant to research involving human subjects. They assess compliance with the federal regulations that govern research ethics, providing insights into how organizations are managing their obligations to protect human subjects. These letters often help identify errors or deficiencies in institutional review board (IRB) processes and human subjects research oversight.

Thus, the combination of these resources equips compliance officers and researchers with the necessary information to develop or update a research compliance work plan effectively, ensuring that they address current issues and align with regulatory expectations.