Database Management
The MSS currently manages more than 100 ongoing research databases. These databases are centralized in the MSS and are managed according to the MSS’s well-developed Standard Operating Procedures (SOP’s) for data management and quality control. Our data management activities are closely monitored by our Data
Management and Quality Control Committee (Gretchen Cloud, MS, Chair), especially in regard to issues related to data quality, patient confidentially and HIPPA compliance. In the last two years we developed two comprehensive databases for our Breast and Ovarian SPORES, and we are currently developing a comprehensive database for the newly funded Brain SPORE. To date the Breast SPORE database has enrolled 764 patients; the Ovarian SPORE, 154 patients.
The MSS has also developed and implemented a number of web-based clinical trial registration and randomization systems. These include registration and randomization systems for the Collaborative Antiviral Study Group of the Center’s Virology Program for three protocols, as well as a West Nile Natural History and West Nile Drug Study registration-randomization system.
In addition, the MSS has developed a sample tracking system (to be deployed) and are currently developing a web-based registration-randomization system for the CAMUS (benign prostate hyperplasia) trial. The systems have facilitated the recruitment of patients for these multi-center clinical trials.
