HIV/AIDS Clinical Trials Network Statistical and Data Management Centers

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.