Clinical Protocol and Data Management

$61,359P30FY2021CANIH

Research Inst Of Fox Chase Can Ctr, Philadelphia PA

Investigators

Linked publications, trials & patents

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Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT ? PROJECT SUMMARY/ABSTRACT Clinical Protocol and Data management (CPDM) at Fox Chase Cancer Center (FCCC) is spearheaded by the Clinical Trials Office (CTO). The CTO provides central management, research support and oversight functions for the conduct of cancer-related clinical trials for the Cancer Center. CTO services are provided for all interventional treatment trials conducted within the Cancer Center, including those at FCCC?s Main Campus, FCCC?s Bone Marrow Transplant Unit and the Temple University Health Science Center. For other cancer relevant clinical research, the CTO facilitates study submission, ongoing management of study materials and annual reviews; however, most researchers utilize research staff within their department to perform the conduct of the study. The CTO has particular responsibility for institutional treatment trials developed by Cancer Center members. Along with the Quality Assurance (QA) group of the CTO, research teams are trained to support the conduct of each trial. Studies are audited internally by the QA group to ensure eligibility and compliance to protocols, as well as appropriate reporting of serious adverse events. They participate in developing corrective action plans for issues identified by internal or external auditors. They also facilitate the review of Early Phase Clinical Trials and Investigator-initiated Trials by the FCCC Data Safety Monitoring Committee. From 2011 to 2014, accrual to Interventional Treatment Trials rose from 358 to 668 (an 87% increase), and to Interventional Investigator-initiated Treatment Trials from 77 to 287 (273% increase).

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