The Central Protocol and Data Monitoring Office (CPDMO) within the St. Jude Comprehensive Cancer Center (SJCCC) provides centralized, administrative, regulatory and educational services to SJCCC members for the conduct of clinical trials-related activities. It is the main coordinating center for protocol development, regulatory and compliance guidance, administrative submissions, protocol registration data, and quality assurance, including monitoring. The overarching goal of the CPDMO is to provide outstanding clinical trials support to SJCCC clinical investigators by: (1) facilitating the development of high quality clinical research trials, within a standardized frame work of trial development and content, so that all appropriate institutional and Federal requirements are met prior to accruing participants; (2) maintaining a centralized submission process for institutional review and approval (CT-SRC and the IRB); (3) ensuring appropriate standards of clinical trials across the institution by encouraging consistent trial conduct and regulatory compliance through the monitoring of trials; (4) ensuring appropriate research participant enrollment via a centralized clinical trial registration system; (5) providing appropriate infrastructure and coordination for clinical trials at our affiliate and collaborating institutions; and (6) adhering to the Data Safety Monitoring Plan approved by the NCI in August 2010. In addition, the CPDMO provides administrative support to the CTSRC to ensure appropriate scientific review of all clinical trials at the SJCCC. Clinical trials are monitored commensurate with the degree of risk involved in study subject participation, as well as the size and complexity of the study. Our position is that trial monitoring and safety reporting is a shared responsibility across all members in the clinical trial process, each having different roles and responsibilities (the Institution and the Principal Investigators and study team(s), oversight committees, monitors, etc.). Particular attention is paid to monitoring investigator-initiated clinical trials, especially those for which there is no independent outside monitoring program.
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