Data Coordinating Center for CPCRN and ICCRN

CPRN 和 ICCRN 数据协调中心

• 批准号: 7251395
• 负责人: J Richard Landis
• 金额: $ 3.7万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7251395
• 关键词: Internet; biomedical registry /referral center; clinical research; computer data analysis; cooperative study; data collection methodology /evaluation; data management; human data; interstitial cystitis; prostatitis; statistical service /center; statistics /biometry

DESCRIPTION (provided by applicant): This is an application from the Center for Clinical Epidemiology and Biostatistics (CCEB) at the University of Pennsylvania Medical Center to serve as the Data Coordinating Center (DCC) for the Chronic Prostatitis Collaborative Research Network (CPCRN) and the Interstitial Cystitis Clinical Research Network (ICCRN). The proposed DCC will provide administrative, biostatistical, data management and research computing leadership for randomized clinical trials (RCTs) within each of these two collaborative networks. In addition, the DCC will serve as a central link among 20 clinical centers, potentially overlapping for both the CPCRN and ICCRN at a few sites, within the Urological Chronic Pelvic Pain Syndromes Collaborative Group (UCPPSCG), the overarching organization formed to facilitate common protocol and data collection procedures across these two networks. With supplemental funding, the DCC would also provide design, analysis and data coordination support for ancillary studies, as approved by the UCPPSCG. The proposed DCC is uniquely positioned with experience-based scientific, technical and administrative leadership to coordinate new RCTs for the UCPPSCG, currently serving as the DCC for the CPCRN (1997-2003) and the ICCTG (1998-2004), with 10 Clinical Research Centers (CRCs) within each network, as well as the previously funded Interstitial Cystitis Data Base (ICDB) Study (1993-1998). To support these multicenter RCTs, the DCC will provide the technical expertise necessary to design and implement data collection, quality assurance (QA), and reporting via a secure World Wide Web (www)-based data management system (DMS), deployed at the CRCs on existing hardware, to facilitate data entry, verification, validation and query resolution, and data transmission over the internet to servers at the DCC. This DMS will support subject screening and enrollment, randomization and data collection at the CRCs, and tracking of subjects and data at the DCC. The DCC will execute procedures for data security and access, QA, storage, back-up, disaster recovery, and will provide periodic monitoring and QA reports. The DCC will provide the scientific design and analysis, logistical and administrative support by organizing meetings of Steering Committees, coordinating development and distribution of RCT Protocols and Manuals of Operations, and providing the NIDDK Program Office, Steering Committees, and the Data and Safety Monitoring Board (DSMB) with interim and final statistical analyses, and collaboration on all scientific publications.

描述（由申请人提供）： 这是宾夕法尼亚大学医学中心临床流行病学和生物统计学中心 (CCEB) 提出的申请，旨在充当慢性前列腺炎协作研究网络 (CPCRN) 和间质性膀胱炎临床研究网络 (CPCRN) 的数据协调中心 (DCC)。 ICCRN）。拟议的 DCC 将为这两个协作网络中的随机临床试验 (RCT) 提供行政、生物统计、数据管理和研究计算领导力。此外，DCC 将作为泌尿科慢性盆腔疼痛综合征协作组 (UCPPSCG) 内 20 个临床中心之间的中心环节，可能与 CPCRN 和 ICCRN 在一些地点重叠，该协作组是为促进共同协议而成立的总体组织以及跨这两个网络的数据收集程序。经 UCPPSCG 批准，DCC 还将利用补充资金为辅助研究提供设计、分析和数据协调支持。拟议的 DCC 具有独特的地位，具有基于经验的科学、技术和行政领导力，可协调 UCPPSCG 的新 RCT，目前作为 CPRN（1997-2003）和 ICCTG（1998-2004）的 DCC，拥有 10 项临床研究每个网络内的中心 (CRC) 以及之前资助的间质性膀胱炎数据库 (ICDB) 研究（1993-1998）。为了支持这些多中心随机对照试验，DCC 将提供设计和实施数据收集、质量保证 (QA) 和通过安全的基于万维网 (www) 的数据管理系统 (DMS) 进行报告所需的技术专业知识，该系统部署在现有硬件上的 CRC，以促进数据输入、验证、验证和查询解析，以及通过互联网将数据传输到 DCC 的服务器。该 DMS 将支持 CRC 的受试者筛选和登记、随机化和数据收集，以及 DCC 的受试者和数据跟踪。 DCC 将执行数据安全和访问、质量保证、存储、备份、灾难恢复程序，并将提供定期监控和质量保证报告。 DCC 将通过组织指导委员会会议、协调 RCT 协议和操作手册的开发和分发，以及向 NIDDK 项目办公室、指导委员会以及数据和安全监测委员会提供科学设计和分析、后勤和行政支持(DSMB) 进行中期和最终统计分析，并在所有科学出版物上进行合作。