The purpose of the Biostatistics and Data Management Core (BDMC) for this P01 grant is to provide a comprehensive, multi-disciplinary resource for design of clinical and basic science studies, development of appropriate and innovative statistical methodology, statistical analysis, and summarization of the results. The Biostatistics and Data Management Core has the following overall goals: To provide statistical consulting and collaboration on the design, conduct, analysis and interpretation for individual projects and across projects and to provide, manage and maintain a high-quality relational research database that supports the research projects and cores while preserving the confidentiality of all subject data.
The specific aims are: (1) Coordinate and manage statistical activities for all research studies to ensure that investigators have ready access to statistical consultation and support. (2) Provide statistical expertise in the design of experiments and studies, including research proposal development, sample size determination, and plans for interim reviews and final analysis. (3) Assist with the writing of statistical components of manuscripts. (4) Review the integrity and statistical soundness of all studies involving human subjects. (5) Provide statistical analysis for all projects using appropriate statistical and computing methodologies, assist in the interpretation and presentation of results. (6) Maintain a computing facility with up-to-date software for statistical analysis to support all research investigators. (7) Provide computer-based tools that facilitate the storage and retrieval of the data generated in the proposed research, thereby creating and maintaining a centralized relational database that provides access to common resources and information. (8) Ensure the accuracy of the data maintained in the database by software based data consistency and quality control systems. (9) Organize and maintain the database to maximize accuracy and accessibility, while maintaining strict confidentiality. (10) Provide detailed descriptions of the available populations and resources for current and future investigators. (11) Collaborate with clinical investigators to design Case Report Forms and provide high-quality data capture/data entry services
All projects proposed in this P01 require biostatistical and data management expertise for optimal study design, patient accrual, data acquisition, quality control to ensure all data are reliable and statistical analysis. These activities are provided by Core C in order to ensure successful completion of the studies proposed in this program.
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