Biostatistics and Data Management
The BDMC is an amalgamation of the Biostatistics, Data Management and Information Systems sub-cores. The Biostatistics sub-core personnel provide study design expertise, development of randomization schemes, sample size calculations including power analysis, and statistical analysis and interpretation of study results. The biostatisticians collaborate with the investigators on grant preparation, protocol development, and conduct and analysis of basic science, pre-clinical and clinical trials. In addition, the Biostatistics sub-core performs report generation for Data Safety Monitoring Boards, data quality monitoring, protocol compliance summaries, and interim and final analyses. The Data Management sub-core provides case report form development, data entry, data review, quality assurance audits, and discrepancy checking and resolution. The Information Systems sub-core provides validated computer, software and database services including database design and maintenance, database and statistical software installation and upgrades, and computer system maintenance. The Information Systems sub-core can design electronic data capture both within the Children’s Hospital firewall and via the World Wide Web.