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.

Business

• For-profit organizations other than small businesses
• Small businesses

Government

• Special district governments
• Federally recognized Native American tribal governments
• County governments
• City or township governments
• State governments
• Public and Indian housing authorities

Education

• Independent school districts
• Public and state institutions of higher education
• Private institutions of higher education

Nonprofit

• Nonprofits non-higher education without 501(c)(3)
• Nonprofits non-higher education with 501(c)(3)
• Other Native American tribal organizations

Miscellaneous

• Other