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Clin ica l Judgement and Centralized Data Management D o n n a Boone, Mei Lai, S tanley A z e n and The Silicon S tudy G r o u p University of Southern California, Los Angeles, California (P-11) The Silicone Study, a 13 center randomized ophthalmic surgical trial, uses complex data collection forms including surgical and treatment complication reports. Some open-ended questions are interspersed on the 13 types of forms containing 789 variables. The Coordinating Center (CC) must exercise clinical judgement in data management and protocol adherence. Therefore, a centralized system of data management and quality control was instituted although distributed systems have become more popular. Components of the system include: 1) computerized in- ventory of form receipt; 2) two-person review of forms; 3) electronic mail inquiry/reply between CC and clinic for clarification or correction; 4) two-person data entry on separate computers using SAS full-screen product programs; 5) program, comparison of the entries; and 6) multiple backup of updated, corrected master file. Tabulations of clinics performance as well as protocol violations are reported biannually to the Study Data and Safety Monitoring Committee and to the entire Technical Group. The system has been evaluated; advantages and disadvantages may have been identified. Types of clinical studies where a centralized system may be the best choice are suggested.

The PoP-PARENT Software System: A Distributed Data Processing and Clinical Trial Management System for the NHLBI BARI Will iam P. A m o r o s o , Dona ld Borrebach, T imo thy E. Kuntz , Lawrence A. Kamons , Jeffrey Mart in , N a n c y Remaley University of Pittsburgh, Pittsburgh, Pennsylvania (P-12) The Epidemiology Data Coordinating Center at the University of Pittsburgh (EDC) serves as the Data Coordinating Center (DCC) for the NHLBI Bypass Angioplasty Revascularization Investi- gation (BARI). BARI is a multicenter randomized clinical trial designed to compare the two therapies of Percutaneous Transluminal Coronary Angioplasty and Coronary Artery Bypass Surgery. The PoP-PARENT Software System has been designed and implemented by the EDC to facilitate distributed data processing among the DCC and 14 participating clinic centers located throughout North America. PoP-PARENT networks a remote microcomputer configuration at each participating clinical center to a front-end microcomputer and DEC VAX 8350 located at the DCC. Each microcomputer configuration includes an IBM PS/2 model 60, HP DeskJet Printer, DynaTech Turn-On and MultiTech 2400 MNP modem. The remote microcomputer at each clinical center is used by clinical personnel to independently randomize new patients, enter, verify, edit all study data, and schedule protocol follow-ups. The telecommunication features of PoP-PAR- ENT facilitate regular and ad-hoc electronic mail between the DCC, clinical centers, and the NIH. Other telecommunication features of PoP-PARENT permit software system maintenance and unattended data transfers between the clinical centers and the DCC 24 hours a day, 365 days a year. In this presentation the technical design and implementation phases of the BARI PoP- Parent Software System are described in detail.

Advanced Multicenter Research (A.M.R.) Salvatore Rago, Marisa De Rosa CINECA lnterUniversity Computing Center, Bologna, Italy (P-13) Five years ago, the Department of Data Analysis at our Institution developed a system for data storage, maintenance and analysis of general data. The strategy adopted was to integrate in an unique environment (VENUS) the best commercially available software.

FOCUS with hierarchical and relational models for DB organization, CMS operating system facilities, SAS and SPSS for analysis, GDDM for graphics, ESE expert system environment, and public data as National Death Index.

So our effort was first to make greater use of the existing commercially available packages rather than write our own and second to create a system easy to use for clinicians but powerful for data processing personnel. We are proposing now, based on a collaboration with research clinicians, the Advanced Multicenter Research (A.M.R.) based on the integration of the most sophisticated informatic resources inside the multicenter clinical trials.

Our goal is to distribute the same data system in all involved clinical institutions and to establish with the facility of the Data Base. Administration and our nationwide electronic network a way to link all the remote centers in a functioning whole.