HIV/AIDS Clinical Trials Network Statistical and Data Management Centers
Contract Overview
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AI Contract Overview
The National Institute of Allergy and Infectious Diseases (NIAID) is seeking applications to support up to four Statistical and Data Management Centers (SDMCs) that will play a central role within four Clinical Trials Networks focused on advancing research related to HIV and HIV-associated diseases. Each SDMC will collaborate with a Leadership and Operations Center, Laboratory Center, and multiple Clinical Trials Units to coordinate study design, data collection, monitoring, and analysis. These centers are responsible for managing clinical and laboratory data, ensuring data quality, regulatory compliance, and continuous performance reporting. They also promote innovative trial design and statistical methodologies, standardize data practices, and maintain validated systems for data capture and integration in line with NIH data-sharing policies. This initiative aligns with the mission of NIH to end the HIV epidemic by enhancing prevention, treatment, and implementation research. The contract is authorized under Sections 301 and 405 of the Public Health Service Act and pertinent federal regulations. The opportunity, posted by the Department of Health and Human Services, specifically the National Institutes of Health, is forecasted for solicitation soon and includes coordination of complex clinical trials networks to achieve scientific goals effectively and compliantly. Interested parties can contact the Division of AIDS for further information.
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Full Description
The National Institute of Allergy and Infectious Diseases (NIAID) seeks to advance the National Institutes of Health (NIH) mission by supporting four Clinical Trials Networks (CTNs) each comprised of a Leadership and Operations Center, Statistical and Data Management Center (SDMC), and Laboratory Center (LC) working with Clinical Trials Units (CTUs), to advance prevention, treatment, and implementation research on HIV and HIV-associated diseases. This NOFO will solicit applications for up to four SDMCs to provide leadership for developing and implementing each CTN research agenda with the goal of ending the HIV epidemic. Each SDMC will coordinate study design and execution, including data collection, monitoring, and analyses. SDMCs manage clinical and laboratory data submitted by CTUs and the LC ensuring data quality, regulatory compliance, and continual reporting of protocol and site performance. SDMCs foster innovative trial design and statistical methods, statistical and data practices harmonization, and ensure validated systems for data capture and integration, according to NIH data sharing policies.
Grant authorities that allow NIAID to forecast this opportunity are as follows: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.
