Research Project
10145030
SUMMARY / ABSTRACT The overall goal of this COBRE is to improve our understanding of challenges in women's reproductive health, including adverse pregnancy outcomes such as preeclampsia, preterm birth, and gestational diabetes. The Biostatistics and Data Management Core is central to achieving the COBRE's overarching goals. The Core will help to support the career trajectories of Project Leaders committed to research in women's reproductive health by providing direct biostatistical and methodological support as well as didactic training to facilitate current and future success. In addition, the Core will provide infrastructure for reproductive research by serving as a shared resource for investigators in our larger research community. The aims of the Biostatistics and Data Management Core are: 1) to provide direct data management and biostatistical expertise for Project Leaders and Mentors in the design and execution of specific research projects, 2) to provide education to Project Leaders addressing elements of study design, implementation, ethics of human subject involvement in research, key components of data management, data security, and biostatistics. 3) We will also serve as a resource for the larger reproductive health research community. Given the overall training goals of this COBRE application and the translational nature of some of the proposed research projects, a key educational component for the Project Leaders will be practical skills in managing and analyzing their own data for both their COBRE projects and their subsequent grant applications as independent investigators. This will be accomplished through project-specific education in design of databases, necessary case report or laboratory forms, standard operating procedures (SOPs), and ultimately data analysis. This approach allows education in areas that are tailored to each Project Leader's specific and evolving area of research expertise. Of note, this includes a range of analytic approaches that will encompass the needs of basic science-oriented projects as well as projects that utilize outcomes from studies involving human subjects. The expertise of the Mentors will complement this Core's interactions with the Project Leaders. In addition, the educational goals of this Core will enhance the breadth and appreciation of the investigators for a broad range of disciplines. This goal will be met through more general instruction to all Project Leaders in the form of bi-monthly didactic sessions addressing elements of study design, ethics of human subject involvement in research, key components of data management, data security, fundamentals of epidemiology and biostatistics.
