The Biostatistics and Data Management Core (BDMC) is being established to provide centralized access for CFAR investigators to services that are critical to the success for HIV/AIDS-related research. The goals of the BDMC are to provide 1) biostatistics/clinical epidemiology study design and analysis support, 2) data management consultation and services, and 3) database development consultation and services, to enhance the quality of the work performed by CFAR investigators.
The aims of the BDMC are to i) advise investigators on study design issues, ii) (re)define and/or refine study hypotheses; iii) conduct sample size/power analyses for basic science/laboratory studies and clinical protocols; iv) provide scientific input into the design and testing of data collection instruments; v) coordinate data management and database development activities; vi) assist with preparation for and writing of final reports, abstracts, manuscripts, and future research proposals; viii) conduct exploratory analyses that may lead to generation of new hypothesis. Core members will facilitate scientific collaboration and translational HIV/AIDS-related research by consulting on study design and analysis; eventually bringing positive basic science results to the attention of clinical researchers. The Core will contribute to the quality of clinical research by consulting with clinical researchers on the development of standardized methodologies for the collection and management of data. The Core will emphasize the necessity for data management methodologies that are compliant with applicable FDA and ICH (International Conference for Harmonization) guidelines. Industry collaboration and funding will be encouraged through assurances that research is conducted in a manner consistent with regulatory requirements. The Core will provide leadership for the database and date warehouse development activities, coordinating the integration of separate, remotely located clinical databases into a centrally located data warehouse. These activities include 1) identification of remotely, individually managed data sources; 2) development of a clinical care cohort intake and update Data Management System (DMS); 3) development of a CFAR data warehouse, a distinct centralized data repository that contains extracts of vital scientific data from all individual sources. This data warehouse will function as a subject registry and a repository that contains extracts of vital scientific data from all individual data sources. This data warehouse will function as a subject registry and a repository of clinical data, supporting project-specific and institution-wide HIV/AIDS-related research. Additionally, the data warehouse will function as a catalog of biological specimens. This centralized catalog facility will communicate to investigators the availability of specimens and will allow more efficient access to specimens; thereby facilitating usage of these valuable specimens.
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