This is a proposal from Boston University Medical Center (BUMC) for the conduct of the Data Coordinating and Analysis Center (DCAC) of the multicenter collaborative study of Event Recordings of High Risk Infants on Apnea Monitors. The goals of the proposal are: to staff the DCAC with highly qualified professionals with skills in neonatology, epidemiology, biostatistics and data management; to provide an organizational framework that weaves together these skills under strong leadership; and to create a DCAC that in responsive and sensitive to the needs of the other components of the study and that constitutes a truly collaborative team effort. The proposal elucidates several of the difficulties and key issues entailed in the design of the study, particularly those in which the DCAC can make a major collaborative contribution. The proposal documents an understanding of the role of the DCAC by outlining lists of specific tasks for the DCAC to undertake in each of the three designated phases of the study, and with an elaboration of the proposed DCAC's activities in data management. These major activities of the DCAC include: collaborate in study design, development of protocol, Manual of operations and data forms; design and implement database management system and quality assurance and quality control systems; train field personnel in data collection; collaborate in refining and modifying study procedures an the study evolves; provide statistical and data management expertise in planning spinoff and satellite studies; respond to data requests from various components of the study; plan and conduct data analyses; collaborate in report writing and presention of study results. The proposal documents the qualifications of the proposed research team in regard to: their depth and breadth of clinical research experience; their achievements in the design, conduct and analysis of randomized clinical trials and observational epidemiologic studies; their recent collaborative efforts in clinical research, particularly in regard to maternal and child health; their track records as effective team players in collaborative, multidisciplinary research; and the rich academic resources that the team can call upon to deploy if needed during the course of the study.
