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Gastroparesis Clinical Research Consortium - Data Coordinating Center

胃轻瘫临床研究联盟 - 数据协调中心

基本信息

批准号：
7941615
负责人：
James A Tonascia
金额：
$ 61.27万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-05-01 至 2011-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7941615
关键词：
Ancillary Study Area Case Report Form Categories Charge Clinical Clinical Research Clinical Trials Clinical Trials Data Monitoring Committees Clinical trial protocol document Communication Conduct Clinical Trials Contracts Data Data Analyses Data Collection Data Coordinating Center Data Sources Databases Development Devices Disease Documentation Enrollment Epidemiologic Studies Epidemiology Etiology Evaluation Gastroparesis Goals Health Insurance Portability and Accountability Act Information Systems Intervention Investigational Drugs Laboratories Lead Leadership Literature Management Information Systems Manuals Medical Monitor National Institute of Diabetes and Digestive and Kidney Diseases Natural History Online Systems Operative Surgical Procedures Outcome Measure Participant Patients Performance Pharmaceutical Preparations Policies Procedures Process Protocols documentation Publications Quality Control Randomized Randomized Clinical Trials Reading Reporting Research Research Ethics Committees Research Infrastructure Resources Safety Sample Size Screening procedure Specific qualifier value Specimen Structure System Teleconferences Therapeutic Human Experimentation Universities Variant Work Writing data management design diabetic disease natural history drug distribution evidence base experience high risk improved meetings member novel quality assurance repository response symposium web site

项目摘要

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

描述（由申请人提供）：