The proposed study, Longitudinal Studies of HIV-Associated Lung Infections and Complications (LSHLI), is planned to be a five-year multicenter, cooperative study. Four to six Clinical Sites (CS) and a Data Coordinating Center (DCC) will be contracted by the National Heart, Lung, and Blood Institute (NHLBI) to carryout the LSHLI Protocol. In this proposal to function as the DCC of this study, C-TASC staff present how their time- tested methods, used to carry out numerous similar NIH-funded studies, can be applied to the LSHLI. We focus on our expertise in the areas of administration, coordination, computer services, and statistical consulting. These services have been developed and used successfully to conduct clinical trials and observational studies for the NIH. As the DCC for this study, C-TASC staff will be responsible for providing oversight of Protocols and Manuals of Procedures development, participating in the development and maintenance of the study documents and procedures, developing and implementing a Web-based Clinical Trials Management System (CTMS), quality assurance monitoring of the study, assisting investigators in the statistical design of analysis plans, performing statistical analyses, supporting specimen banking activities, facilitating the sharing of data and specimens, arranging study meetings and conference calls, and providing the NHLBI with clean and complete data files. C-TASC is in the process of closing a large study for the National Institutes of Allergy and Infectious Diseases (NIAID) and these staff will be available to work in the LSHLI. Our long history of working with the NHLBI and NIAID ensures that the proposed staff have the requisite knowledge to collect, analyze and interpret the highly specialized data that will be generated in this study. A key feature of the LSHLI is that data will be collected for several smaller protocols. This is a study format familiar to C-TASC in the Women and Infants Transmission Study (WITS) and the Lung Tissue Research Consortium (LTRC). C-TASC staff have already developed similar chapters to the ones that will be required in the LSHLI Protocols and Manuals of Procedures in these two other studies. Likewise, forms, tracking procedures, review procedures, database programming, and statistical analysis techniques have been extensively developed in these two studies and can be easily adapted to the LSHLI. We look forward to serving as the DCC for the LSHLI should C-TASC receive this award.
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