Hepatitis B Research Network - Data Coordination Center

 描述（由申请人提供）：建立了B型肝炎研究网络（HBRN），以促进“B型肝炎的研究，重点是阐明发病机制和自然史，并开发治疗和控制手段”。HBRN是一项合作协议，包括13个联盟的28个合作临床中心、一个免疫学中心、一名NIDDK项目科学家和一名NIDDK项目官员以及一个数据协调中心（DCC）。HBRN包括2项自然史研究，其中一项包括成人和其他患有B型肝炎病毒（HBV）感染的儿科受试者。还有3项临床试验和2项免疫学参数研究。作为DCC，我们与HBRN成员合作，为各种研究的研究设计，研究实施和数据分析提供支持。我们与HBRN人员合作，开发了数据收集工具和流程，以促进收集完整和准确的数据。我们开发并维护分布式数据输入系统，并维护来自临床和免疫学中心的临床、实验室和其他相关信息的安全中央数据库。我们已经确定并与其他中心设施（病毒学实验室、DNA提取、病理染色、药物分配）签订合同，并与NIDDK资助的生物样品和数据库进行协调。我们合作制定安全性和有效性分析计划，并为HBRN会议、科学会议以及出版物和监督及监管机构准备材料。DCC协调HBRN的所有活动，包括指导委员会、小组委员会的会议和电话会议，以及向数据和安全性监查委员会的报告。我们服务于所有小组委员会，监督和促进出版物和演示文稿和辅助研究小组委员会的过程。我们将分享为HBRN收集的数据，参与与更广泛的科学、临床和一般社区的翻译活动，并存档所有数据、研究干预材料，并在研究结束时协调存档所有标本。

 DESCRIPTION (provided by applicant): The Hepatitis B Research Network (HBRN) was established to promote "research in hepatitis B focusing upon elucidating the pathogenesis and natural history and developing means of treatment and control". The HBRN is a Cooperative Agreement that includes 28 collaborating Clinical Centers at 13 consortia, an Immunology Center, a NIDDK Project Scientist and a NIDDK Project Official, and a Data Coordination Center (DCC). The HBRN includes 2 natural history studies, one that includes adults and the other pediatric participants with hepatitis B virus (HBV) infection. There are also 3 clinical trials and2 studies of immunological parameters. As the DCC, we work with the HBRN members to support all aspects of study design, study conduct, and data analysis for the various studies. In collaboration with HBRN personnel, we developed data collection instruments and processes to facilitate collecting complete and accurate data. We developed and maintain the distributed data entry system and maintain a secure, central database of clinical, laboratory, and other relevant information from the Clinical and Immunology Centers. We have identified, and contract with, other central facilities (virology laboratory, DNA extraction, pathology staining, drug distributio) and coordinate with the NIDDK-funded Biosample and Data Repositories. We collaborated with developing safety and efficacy analysis plans and prepare materials for presentations at HBRN meetings, scientific conferences, and for publications and oversight and regulatory bodies. The DCC coordinates all activities of the HBRN, including meetings and conference calls for the Steering Committee, subcommittees, and presentations to the Data and Safety Monitoring Board(s). We serve on all subcommittees, monitor and facilitate the Publications and Presentations and Ancillary Studies subcommittee processes. We will share data collected for the HBRN, participate in translation activities with the wider scientific, clinical, and general community and archive all data, study intervention materials, and coordinate archiving all specimens at the end of the study.