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.
