SOM Clinical Research SOPs

The SOM CRSO is dedicated to enhancing the efficiency and compliance of clinical research operations. To achieve this, the CRSO is developing a comprehensive set of Standard Operating Procedures (SOPs). These SOPs offer clear and consistent guidelines to assist investigators and study teams across the SOM in conducting human subjects research in compliance with the Federal and State Regulations, Good Clinical Practice, institutional policies and procedures, and recognized best practices.

The SOM SOPs are designed to be high-level, offering a framework that allows individual teams the flexibility to develop their own detailed work instructions. This approach ensures that while overarching guidelines are followed, teams can adapt processes to fit their specific needs. Procedures are generally listed in the order they must be completed, with the understanding that some steps may occur concurrently.

The CRSO SOP on SOPs outlines the systematic process for developing, implementing, and maintaining these SOPs, ensuring they remain relevant and effective in guiding clinical research activities.