This is a resubmitted proposal for the Statistics, Epidemiology, and Data Management (SED) Core. The Core has been thoroughly redesigned in order to bring its functions in line with those of standard data management and statistical analysis units for major, randomized controlled trials. This entailed creating a centralized Core that has primary responsibility for statistical and database design; data management; problem-solving and quality assurance of data; including routine reports and uniform definitions and data entry screens; and statistical analyses, from the planning stages right on through to final analysis and publication. The SED Core will coordinate all these activities and will maintain the highest standards of data and analytical integrity. In addition, we have retained the highly successful Epidemiology Consultation Clinic. Specifically, the SED Core will: 1. provide all statistical planning, analytic monitoring, statistical analysis, and analytic publication review for the four behavioral intervention trials proposed in this cycle of the HIV Center; and conduct methodologic research seeking the best design for analytic solutions to problems encountered during the trials as well as others that may arise; 2. provide expert consultation on matters of study design and manuscript preparation by means of (i) a biweekly Consultative Clinic for Center investigators, Core members, and other interested parties in which ongoing research problems such as biased selection, measurement error, subject accrual, non-compliance, sample attrition, missing data, unblinding and other protocol violations, evasive answer bias, confounding bias in non- randomized subgroup analyses, and epidemiologic causal interference will be addressed; and (ii) a second biweekly session to review manuscripts in preparation; and 3. provide the centralized resource for all data management needs including database design, implementation, and modification; data entry and verification; data retrieval for statistical analysis and report generation; and maintenance of data security and confidentiality. Thus, the SED Core will play a crucial and integral part in HIV Center III, enhancing the conduct of the research according to the highest standards of conduct for randomized controlled trials.
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