SOM Clinical Research SOPs
The SOM CRSO is creating a portfolio of Standard Operating Procedures (SOPs) to address risks and inefficiencies in clinical research operations and provide clear and consistent instructions to support investigators and study teams in carrying out the research in compliance with the Code of Federal Regulations, Good Clinical Practice, institutional policies and procedures, and identified best practices, as applicable. SOM SOPs support uniformity and quality in the performance of specific activities that are required by these comprehensive and often complex regulations.
The SOPs are widely applicable to all human subjects research conducted across the SOM as represented in the following 8 SOP categories:
Once draft SOPs are developed and undergo multi-level review, they are disseminated for public review and feedback to seek input from all SOM personnel. The CRSO SOP on SOPs details the full process for developing, implementing, and maintaining SOPs.