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Core A: Administration

核心A：管理

基本信息

批准号：
10532091
负责人：
Deborah J Anderson
金额：
$ 21.26万
依托单位：
BOSTON UNIVERSITY MEDICAL CAMPUS
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-14 至 2026-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10532091
关键词：
Achievement Adherence Antibodies Antibody Formation Antigen Targeting Atopobium vaginae Award Biological Blood Boston Clinical Clinical Data Clinical Management Clinical Trials Clinical Trials Database Communication Contraceptive Agents Contraceptive methods Data Development Ensure Environment Experimental Designs Film Funding Goals Grant Guidelines HIV-1 Human Human Herpesvirus 2 IgG1 Immobilization Individual Industrialization Industry Infertility Infrastructure Leadership Libraries Liquid substance Methods Monitor Monoclonal Antibodies National Institute of Allergy and Infectious Disease National Institute of Child Health and Human Development Nicotiana Performance Phase I Clinical Trials Positioning Attribute Preclinical Testing Prevention Program Reviews Publications Reagent Research Research Personnel Research Project Grants Resource Allocation Safety Schedule Scientist Sexually Transmitted Diseases Site Specificity Sperm Agglutination Statistical Data Interpretation Technology Testing Translational Research United States National Institutes of Health Universities Vagina Vaginal Route of Drug Administration Woman base clinical database data acquisition data management data sharing experience innovation medical schools meetings pathogen pre-clinical programs research and development sperm cell statistical service statistics success symposium web site

项目摘要

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.

行政核心--摘要波士顿大学医学院避孕研究中心汇集了由临床、工业和基础科学家组成的经验丰富的团队开发和测试新的避孕产品ZB- 06，一种释放抗精子抗体的阴道膜，即人类避孕抗体(HCA)。Hca曾经是最初从不育但其他方面健康的妇女的血液中分离出来，并以精子上的抗原为靶标实现精子的快速凝集和固定。BUSM-CRC的成功取决于行政管理在协调两种避孕措施发展方面提供科学和行政领导的核心研究项目和一个避孕转化研究项目组成了该计划。这个管理核心还将维护临床数据库，提供统计服务，并协调数据和材料的获取和共享，使研究进展以一种综合迭代的方式满足个别项目和方案里程碑，行政核心的具体目标是： 1.提供科学的领导和行政监督。具体而言，行政核心将建立一个执行委员会(EC)，负责持续评估项目和核心里程碑、资源对实验设计的分配和更改。行政核心还将召集外部科学咨询小组(SAP)每年审查该计划。行政核心将促进通过预定的电话会议和调查人员会议进行沟通，提供资金和行政支持，并确保遵守机构和联邦指导方针。 2.协调数据和材料的获取和共享，以确保项目和计划达到了里程碑。行政核心将负责试剂/研究材料和数据管理和分享计划，以及监测里程碑成就。 3.管理两项临床试验的临床数据库和统计分析。