PRMS, iRIS, and the Protocol Management Changes Coming in July
May 14, 2019
PRMS stands for Protocol Review and Monitoring System and is DF/HCC’s system for supporting oncology clinical trials across the consortium medical centers of: Beth Israel Deaconess Medical Center, Boston Children’s Hospital, Brigham and Women’s Hospital, Dana-Farber Cancer Institute, and Massachusetts General Hospital.
iRIS is the PRMS system that has been selected to be implemented within DF/HCC. iRIS will replace our current systems that include paper smart forms, OHRS Submit and P360 among others. It is one single system, that will allow the research team to submit its regulatory forms electronically to the review board where the board triages, processes and approves the submission for ethical and regulatory accuracy.
The process to handle clinical trials from across the DF/HCC member institutions is complex and ever-evolving, with over a thousand open protocols in 2018 with total accrual of tens of thousands of patients center-wide. Activation times have always been a focus by center leadership, and although efforts have reduced activation timelines from >200 days previously to ~155 currently, there is still more work to be done.
Coming in July, 2019, the iRIS system will help accomplish the goal to enhance the entire submission process, and be able to activate trials faster for our patients. Over the next 2 months, we will be providing additional information and details about the timeline for the iRIS system go-live to make the transition as seamless as possible.
In the meantime, should you have any questions about these changes or the larger goal of streamlining the protocol activation process, I encourage you to reach out to me or to Farah Daftary, Vice President, Clinical Research Operations.
Senior Vice President, Research Administration, Dana-Farber Cancer Institute
Associate Director for Administration, Dana-Farber/Harvard Cancer Center