Data and Safety Monitoring/NIH Policy

Clinical Trials Office and Data and Safety Monitoring (DSM) Description The Masonic Cancer Center (MCC) Clinical Trials Office (CTO) was formally established in 2001 with the goal of enhancing MCC members' ability to conduct clinical cancer research by providing centralized and specialized resources and expertise. It assists MCC investigators in developing, activating, and completing scientifically meritorious clinical trials in a high-quality, efficient, cost-effective, centralized manner. At the same time, it ensures the validity and integrity of data in order to fulfill all NCI, federal, and local regulatory requirements. In fiscal year 2012, the CTO opened 42 clinical trials to accrual. As of July 2012, 296 active clinical trials were using CTO services, of which 134 were investigator initiated, 82 were National Cooperative Group trials, and 80 were industry trials. The CTO is currently managing 27 Investigational New Drug Application (IND)/lnvestigational Device Exemption (IDE) trials. A total of 1220 patients (active treatment and follow-up) are currently being followed by the CTO. The CTO focuses on investigator-initiated trials and the translation of basic scientific findings to clinical trials, effectively leveraging MCC resources for the management of our therapeutic translational pipeline. The CTO provides the following major areas of support to MCC investigators: clinical services and data management, regulatory affairs, ClinicalTrials.gov and Clinical Trials Reporting Program registrations and updates, protocol development, clinical trial finance management, project management, system management, clinical trial monitoring and auditing. The MCC Data and Safety Monitoring Plan (DSMP) details the roles and responsibilities of 3 accountable units (PI, MCC, and the University of Minnesota) and the processes that are used by these accountable units to ensure that the highest-quality clinical research is conducted while participant safety is optimized. The current DSMP was approved by the NCI on February 16, 2012. The PI is responsible for all aspects of trial conduct, including clinical trial management, data acquisition, and data and safety monitoring. The MCC has the responsibility of clinical research oversight. The University has oversight for conflict of interest and regulatory standards.