This application, submitted by the Research Triangle Institute (RTI) is to serve as the Data Coordinating Center (DCC) for the proposed perinatal studies and interventions in minority populations (RFA: HD/NR/OMP-93-010). The goals of the study are to conduct research aimed at understanding the variables related to high infant mortality and to develop and evaluate interventions designed to reduce this mortality and related outcomes. The study will take place in Washington, DC. The DCC in this study will be expected to have primary responsibility for collecting, editing, storing and analyzing study data; take an active role in developing the study materials develop a data collection system; oversee quality control; prepare reports for the Steering Committee; assist intervention sites will study design, timely recruitment, randomization, data collection and data analyses; and prepare a final database. As the DCC for the study, RTI will be involved in all phases of the project. During the planning phase, RTI will contribute to the development of the study protocols, data collection forms and manuals of operation. We will have a major role in the development of the statistical aspects of the study design; procedures for collection of data, data processing and data analyses; and quality control and randomization procedures. RTI will pretest the data collection forms and will train site personnel in all aspect of data collection. We will work closely with the sites to prepare for the beginning of recruitment. During the implementation phase, RTI will receive, process, edit and store study data from the various sites. We will also implement systems for monitoring the accuracy completeness and timeliness of the site data and for timely communication to the study investigators. We will perform statistical analyses of the accumulating study data and will report the results periodically to the Steering Committee. We will also assist the sites as time permits with their individual data analysis. During the final phase of study (close out and data analyses), RTI will assist the sites with study close out; continue to monitor analyze and report study results; prepare a final database and assist in the preparation of scientific reports for publication and presentation at scientific meetings. In addition, throughout the study RTI will provided logistical support to the NICHD Program Office and the Steering Committee as requested (e.g., arranging meetings, preparing minutes of Steering Committee meetings). RTI's proposed data collection and data processing systems involve well developed data entry, communications, and data management software used on many similar studies. Training of site staff to ensure standardization of procedures across sites will also follow well established methods used on several previous multi-site studies. The proposed DCC staff have extensive experience in cooperative multi-site studies which the Institute has been conducting for over twenty years and includes a strong interdisciplinary team of epidemiologists, biostatisticians, a sociologist, computer programmers, and data coordinators. This staff also has experience with multiprotocol multi-site studies (i.e., multi-site studies with different interventions and study populations).
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