About the CTSRMC

Overview of the Clinical Trials Scientific Review and Monitoring Committee (CTSRMC)
The Abramson Cancer Center (ACC) established a comprehensive Protocol Review and Monitoring System (PRMS) in 1992 known as the Clinical Trials Scientific Review and Monitoring Committee (CTSRMC). The Committee's focus is scientific merit, priorities, and progress of cancer relevant protocols conducted within the University of Pennsylvania and Children's Hospital of Philadelphia (CHOP). Presented below is an overview of the PRMS as administered by the CTSRMC.

The Dean of the School of Medicine affirmed the Committee as the required body within the School of Medicine for reviewing and approving all cancer-related protocols prior to full University IRB approval. The Perelman School of Medicine (PSOM) is committed to supporting the mission of the ACC CTSRMC, and has worked collaboratively with the ACC to achieve the mission outlined by NCI in the CCSG. Because the ACC recognizes the critical role human subjects research plays in providing treatment options to subjects and expanding our knowledge of this life-threatening disease, the CTSRMC Chairs and Director report directly to the Cancer Center Director to ensure the needs of the core Grant are met, however, in order to maintain the integrity and autonomy of this Committee, the Cancer Center Director does play a role in the scientific review process and does not influence any of the Committee's decisions.

Consistent with NCI Core Grant guidelines, the CTSRMC reviews the scientific merit, statistical design, feasibility, competitiveness, ongoing accrual performance and scientific progress of cancer-related protocols. However, different levels of review exist based on the sponsor type, funding source, study populations and study design.

Pediatric protocols are reviewed by an expert Sub-committee of the CTSRMC. The Pediatric Protocol Review and Monitoring Committee (PPRC) is based at Children's Hospital of Philadelphia (CHOP). The PPRC follows the same policies and procedures as the CTSRMC and is overseen by the CTSRMC Chairs and Director.

Per the institutional agreement with the NCI, the Penn and CHOP IRBs will not grant full approval to begin enrolling on any cancer-based protocol without receiving documentation of full CTSRMC/PPRC approval. This means that even if the IRB has reviewed the study, an investigator may not start accruing subjects until the receipt of a written approval letter from the CTSRMC.

Structure
The CTSRMC is Co-Chaired by Dr. Sunita Nasta and Dr. John Plastaras, MD, PhD and the CTSRMC Director is Vicki Sallée, PhD, MS, RD, RAC. Vicki is responsible for the overall organizational management of the committee, education, training and setting standards for study conduct.