Standard Operating Procedures for Clinical Research
VCU/VCUHS Shared Clinical Research Standard Operating Procedures (SOPs)
Several months ago, VCU and VCUHS clinical research leadership assembled a small team to draft a set of shared SOPs outlining uniform clinical research operational practices. In total, there are now 51 Draft SOPs which are available for comment at the following website (eID required): https://research.vcu.edu/secure/compliance_program/sops.htm
Standard Operating Procedures (SOPs) support quality, efficiency, and compliance across the entire VCU Clinical Research Enterprise, in addition to ensuring that clinical research activities are carried out in accordance with federal, state, and local regulations and policies. In order to establish SOPs that would best serve clinical research teams, each SOP includes active links to applicable regulations, VCU IRB Written Policies and Procedures, VCU Health System Policy, VCU Compliance Notices, and other resources. While SOPs define what common standards are shared across the enterprise, working guidelines may still be developed by schools, centers, or other groups to define how these standards are met.
How You Can Get Involved: At this time, comments are due by June 30, 2017 for Section 1: Administrative/Executive. The files in this section are available in word for track changes and/or comment, which should be sent to CRSOP@vcu.edu. In addition, your school or center may establish small groups and/or internal procedures supporting review.
Further questions should be directed to: Mary Harmon (VCU Health) and Lisa Ballance (VCU Office of the Vice President for Research), Catherine Brown (VCU Massey Cancer Center), Rashmi Pershad (VCU School of Medicine), and Joelle Lemmons (VCU Wright Center for Clinical and Translational Research).
Categories Policies & Guidance