Clinical Protocol and Data Management

PROJECT SUMMARY/ABSTRACT Part I: Clinical Protocol and Data Management The primary mission of the Clinical Protocol and Data Management team, also referred to as the Cancer Clinical Trials Office (CCTO), is to assist Tisch Cancer Institute investigators in the development, conduct, and reporting of innovative clinical research in an efficient, regulatory-compliant, and scientifically sound manner. The CCTO comprises the following functions: study coordination, data management, regulatory management, pre-award budgeting, training and education. Part II: Data and Safety Monitoring All cancer clinical trials are monitored according to the guidelines set forth in the TCI Data and Safety Monitoring Plan (DSMP) which was previously reviewed and approved by the NCI. A formal Data and Safety Monitoring Committee (DSMC) was established in 2008 to ensure that investigator-initiated clinical trials in the TCI are compliant with the data and safety monitoring plans approved by the PRMC. The DSMC is accountable to and reports to the Associate Director for Clinical Research. Part III: Inclusion of Women and Minorities and Part IV: Inclusion Across the Lifespan TCI successfully recruits significant proportions of minority patients onto clinical trials. The TCI is highly committed to adhering to CCSG principles in providing state-of-the-art evidence-based, family-and-child- oriented, multi-disciplinary cancer treatment for women, minorities, and patients of all ages.