Protocol Review & Monitoring
The Protocol Review and Monitoring System (PRMS) ensures adequate internal oversight of the scientific aspects of all cancer clinical trials conducted at the Stephenson Cancer Center. Per NCI CCSG Guidelines, there are two stages of review of new clinical trial protocols.
Stage One: Disease Groups and Feasibility Review
- Disease Site Groups: Review potential new protocols to assess applicability to patient populations, identify competing trials, and alignment with Disease Group goals.
- Feasibility Review Committee: Assesses the operational complexities of protocols approved by the Disease Groups to ensure effective resource utilization, operational feasibility, and appropriateness of cost allocation.
Stage Two: Protocol Review and Monitoring Committee (PRMC)
- Protocol Review and Monitoring Committee: Reviews protocols recommended for IRB submission to evaluate scientific merit, statistical validity, design feasibility, inclusion of underrepresented populations, and study prioritization. Makes recommendations for enhancing protocol design when necessary.
- The PRMC conducts continuing review of open protocols, focusing on accrual progress, new safety information, and continuing scientific relevancy to ensure effective study portfolio management and allocation of CTO resources. The PRMC has the authority to terminate clinical trials not meeting accrual goals or lacking continued scientific relevancy.
New Submissions
The following form should be included with any new protocol submission to the Protocol Review and Monitoring Committee.
- 2024 PRMC Deadlines: Protocol Review Timeline and Deadlines
- If you wish to contact the committee coordinators with additional questions, please send an email to scc-prmc@ouhsc.edu.
PRMC Committee Chairs
Adam Asch, MD
Melissa Craft, PhD
