About DAIDS and the DAIDS RSC | DAIDS Regulatory Support Center (RSC)

About DAIDS and the DAIDS RSC | DAIDS Regulatory Support Center (RSC)

About DAIDS and the DAIDS RSC

The Division of AIDS (DAIDS) was formed in 1986 to develop and implement the national research agenda to address the HIV/AIDS epidemic. Toward that end, the Division supports a global research portfolio on HIV/AIDS, its related co-infections, and co-morbidities. With the ultimate goal of creating an "AIDS-free Generation," the Division continually develops and supports the research infrastructure and scientific expertise needed to enable innovative approaches aimed at:

1. Halting the spread of HIV through effective and acceptable prevention strategies and a preventive vaccine
2. Treating and curing HIV infection
3. Establishing treatment and prevention strategies for the HIV co-infections and co-morbidities of greatest significance
4. Partnering with scientific and community stakeholders to implement effective interventions

Organizationally, DAIDS is comprised of the Office of the Director (OD) and four scientific programs. Within the OD are the: 1) Workforce Operations, Communications, and Reporting Branch; 2) Science Planning and Operations Branch; 3) Office of Clinical Site Oversight, which includes the Pharmaceutical Affairs Branch, Monitoring and Operations Branch, Africa and the Domestic Partners Branch, and Asia and the Americas Branch; and 4) Office for Policy in Clinical Research Operations, which includes the Regulatory Affairs Branch, Clinical Research Resources Branch, and the Protection of Participants, Evaluation and Policy Branch.

The DAIDS Regulatory Support Center (RSC) is a contract-based organization that provides comprehensive clinical regulatory support for all NIAID/DAIDS-supported and/or -sponsored network and non-network clinical trials, both domestic and international. The DAIDS RSC provides day-to-day support for all regulatory activities using the DAIDS Enterprise System (DAIDS-ES) within the NIAID Clinical Research Management System (NCRMS(link is external)). Use of the DAIDS-ES enables the DAIDS RSC to exchange information directly with database systems utilized by NIAID/DAIDS-sponsored Group/Network Operations Offices, Data Management Centers, and other collaborators, to ensure efficient and effective integration of regulatory information in support of NIAID/DAIDS. The DAIDS RSC Contracting Officer’s Representative (COR) provides technical oversight of the DAIDS RSC Contract.

For more information about DAIDS collaborators and their roles in the clinical trial lifecycle, view the DAIDS Collaborators Guidepdf

These pages describe several DAIDS groups and the DAIDS RSC Teams who support them:

• The DAIDS Regulatory Affairs Branch (RAB) and the DAIDS RSC Regulatory Team
• The DAIDS Protection of Participants, Evaluation, and Policy Branch (ProPEP) and the DAIDS RSC Human Subjects Protection Team
• The DAIDS Protocol Registration Team (PRT) and the DAIDS RSC Protocol Registration Office
• The DAIDS Safety and Pharmacovigilance Team (SPT) and the DAIDS RSC Safety ​Office
• The DAIDS RSC Case Report Form Management Team
• The DAIDS Clinical and Prevention Science Review Committees (C/PSRC) and the DAIDS RSC Science Review Committees (SRC) Team
• The DAIDS RSC Clinical Study Information Office