Core A: Administration

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ADMINISTRATIVE CORE – ABSTRACT The Contraception Research Center at Boston University School of Medicine (BUSM-CRC) brings together an experienced team of clinical, industrial and basic scientists to develop and test a new contraceptive product, ZB- 06, a vaginal film that releases an antisperm antibody, Human Contraception Antibody (HCA). HCA was originally isolated from the blood of an infertile but otherwise healthy woman and targets an antigen on sperm to effect rapid sperm agglutination and immobilization. Success of the BUSM-CRC relies upon an Administrative Core that provides scientific and administrative leadership in coordinating the two contraception development research projects and one contraceptive translational research project that make up the program. The Administrative Core will also maintain the clinical database and provide statistical services, and coordinate data and materials acquisition and sharing so that the research progresses in an integrated iterative fashion to meet individual project and programmatic milestones, The Specific Aims of the Administrative Core are: 1. To provide scientific leadership and administrative oversight. Specifically, the Administrative Core will establish an Executive Committee (EC) for ongoing assessment of project and core milestones, resource allocation and changes to the experimental design. The Administrative Core will also convene an external Scientific Advisory Panel (SAP) to review the program annually. The Administrative Core will facilitate communication through scheduled conference calls and investigator meetings, provide financial and administrative support, and insure adherence to institutional and federal guidelines. 2. To coordinate data and materials acquisition and sharing to insure that project and program milestones are met. The Administrative Core will be responsible for the reagent/research material and data management and sharing plan, and for monitoring milestone achievements. 3. To manage the clinical database and statistical analysis for the two clinical trials.