Gastroparesis Clinical Research Consortium - Data Coordinating Center

描述（由申请人提供）： 约翰霍普金斯大学临床试验中心（CCT）提议作为胃轻瘫临床研究联盟的数据协调中心（DCC），该联盟将专注于胃轻瘫的病因、自然史和治疗。DCC将负责联合体的组织，包括通过指定成员来定义委员会结构，管理成员选择过程，以及编写每个委员会的费用，以获得联合体批准。DCC将协调联合体所需的所有通信方面，包括会议、电话会议和基于网络的通信。发展协调委员会将支持联合体政策的制定，包括关于介绍、出版物和辅助研究的政策。DCC将与NIDDK和指导委员会（SC）合作，提供生物统计和信息系统基础设施，以快速有效地设计和进行胃轻瘫潜在治疗的多中心随机临床试验。DCC将从文献或其他来源中挑选关于标准化结局指标的信息，以确定每项拟议研究的样本量。DCC将在联合体研究的实施、进行和质量控制方面采取主动。DCC将为数据安全性和监测报告以及联合研究的演示和出版物提供生物统计分析。在CCT协调的正在进行的研究网络所使用的系统的基础上，DCC将提供一个全面的信息管理系统，包括设计文件的开发和分发（方案、手册、病例报告表、政策备忘录等），用于访问最新研究相关材料的研究网站，以及一个基于网络的数据管理系统（用于筛选和招募患者，包括临床试验的随机化程序，用于数据采集和显示，用于招募报告，以及质量控制报告，以提高临床中心的绩效）。DCC将根据需要提供其他支持，包括建立集中实验室、阅读中心、药物配送中心或样本库资源。DCC在FDA/IND流程方面拥有丰富的经验，并可根据需要协助联合体处理这些事项。DCC将监测联合体的IRB和HIPAA合规性

DESCRIPTION (provided by applicant): The Johns Hopkins University Center for Clinical Trials (CCT) proposes to serve as the Data Coordinating Center (DCC) for a Gastroparesis Clinical Research Consortium, which will focus on the etiology, natural history, and therapies for gastroparesis. The DCC will be responsible for organization of the consortium including definition of the committee structure by specifying membership, managing the member selection process, and writing the charges for each committee, subject to consortium approval. The DCC will coordinate all aspects of communications needed by the consortium, including meetings, teleconferences, and web-based communications. The DCC will support the development of consortium policies including policies on presentations, publications, ancillary studies. The DCC will work with the NIDDK and the Steering Committee (SC) to provide the biostatistical and informations systems infrastructure to rapidly and efficiently design and conduct multicenter randomized clinical trials of potential treatments for gastroparesis. The DCC will cull information from the literature or other sources for data on standardized outcome measures needed to make sample size determinations for each proposed study. The DCC will take the initiative in the implementation, conduct, and quality control of consortium studies. The DCC will provide biostatistical analysis for data safety and monitoring reports and for presentations and publications for consortium studies. Building on systems used by ongoing research networks coordinated by the CCT, the DCC will provide a comprehensive information management system including the development and distribution of design documents (protocols, manuals, case report forms, policy memoranda, etc), a study website for up-to-date access to study-related materials, and a web-based data management system (for screening and enrollment of patients including randomization procedures for clinical trials, for data capture and display, for reporting on recruitment, and for quality control reports to improve clinical center performance). The DCC will provide other support, as needed, including the establishment of centralized laboratories, reading centers, drug distribution center, or specimen banking resources. The DCC has extensive experience with the FDA/IND process and can assist the consortium in these matters, as required. IRB and HIPAA compliance for the consortium will be monitored by the DCC