The goals of the Biostatistics and Data Management Core (BDMC) are to provide biostatistical study design and statistical analysis support to enhance the scientific quality of the four projects in this SCOR. Core biostatisticians will collaborate with research investigators to investigate the role of hyperbaric oxygen in the clinical and experimental studies as well as develop predictive models for surgical complication. The BDMC will also provide the data management and research computing expertise necessary to design and implement data entry, data quality assurance and data reporting for the randomized controlled trial in Project 1. The BDMC will support subject enrollment, eligibility confirmation, randomization and data collection and tracking of subjects. The BDMC will execute procedures for data security and access, data quality control, storage and back-up. Core members will be involved in biostatistical and data management activities for all four projects.
The specific aims of the BDMC are to: 1. Biostatistics a. advise investigators on study design issues, including sample size/power considerations, for basic science/laboratory studies and clinical protocols; b. conduct statistical analyses of data from laboratory projects and clinical investigations to address specific research hypotheses defined in the project-specific proposals; c. assist with preparation for and writing of final reports, abstracts, manuscripts, and future research proposals; d. conduct exploratory analyses that may lead to generation of new hypotheses. 2. Data Management a. design, develop and implement the database management system (DMS) for the randomized clinical trial in Project 1; b. provide training and assistance for project-specific research staff in the conduct of the clinical protocol and use of the DMS; c. conduct all phases of quality assurance, validation, query resolution and reporting for the protocol.
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