The Protocol Management Office (PMO) provides a centralized resource to support the activation and management of all cancer treatment trials conducted at Fox Chase Cancer Center (FCCC), as well as selected prevention, imaging and data/sample collection trials. The PMO also provides scientific and technical review, ensures compliance with regulatory guidelines and standards, manages patient registration, treatment and data management, reporting to outside sponsors and communication with principal investigators and statisticians and collects and prepares pharmacokinetic and genomic samples for processing at FCCC or for shipping to outside sponsors. Sixty-eight investigators have opened clinical trials through the PMO during the last grant period, including 58 with peer-reviewed funding. Investigator Use over the past five years represents use for all five CCSG Programs. Additionally, all investigators at the Center have access to the Protocol Support Laboratory (PSL), a centralized laboratory for sample collection and processing, and the Protocol Specific Monitoring System for study evaluation and monitoring. During a time of reorganization at the Center, institutional support has been provided to several areas to improve and expand key areas in support of the clinical trials program. Specifically, the regulatory affairs team has been expanded to take on additional responsibilities in support of investigators at the Center;the informatics platform was expanded to additional outside affiliates for tracking of enrollment at extramural sites, and additional capabilities were added to enhance reporting and tracking of PMO activity and finally;work has been undertaken to link the database for the clinical trials run by the PMO with that of the Population Studies Facility (PSF). Currently, the PMO is working towards full integration of the Extramural Research Team, which provides monitoring and support to affiliates participating in FCCC-sponsored clinical trials with completion of this project in the next several months.
The ability to safely conduct high-priority clinical research is a mission-critical activity of the Center. The PMO provides a centralized resource that participates at all levels in the activation and conduct of clinical trials, including attention to scientific, ethical, and regulatory issues, protocol compliance, and the objective management of verifiable data for each study.
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