Hepatitis B Research Network - Data Coordination Center

 描述(由申请者提供)：乙肝研究网络(HBRN)的建立是为了促进“致力于阐明乙肝的发病机制和自然病史以及发展治疗和控制手段的研究”。HBRN是一项合作协议，包括13个联合体的28个合作临床中心、一个免疫中心、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项自然病史研究，其中一项研究包括成人和其他感染乙肝病毒(乙肝)的儿科参与者。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，支持各种研究的研究设计、研究实施和数据分析的方方面面。我们与HBRN人员合作，开发了数据收集工具和程序，以促进收集完整和准确的数据。我们开发和维护分布式数据输入系统，并维护一个安全的中央数据库，其中包括临床和免疫中心的临床、实验室和其他相关信息。我们已经确定了其他中央设施(病毒学实验室、DNA提取、病理染色、药物分配)并与之签订了合同，并与NIDDK资助的生物样本和数据存储库进行了协调。我们合作制定安全性和有效性分析计划，并为HBRN会议、科学会议和出版物以及监督和监管机构准备演示材料。数据中心协调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，以及向数据和安全监测委员会(S)介绍情况。我们为所有小组委员会提供服务，监督和促进出版和演示以及辅助研究小组委员会的工作。我们将分享为HBRN收集的数据，与更广泛的科学、临床和普通社区参与翻译活动，并在研究结束时存档所有数据、研究干预材料，并协调存档所有标本。

 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.