The Office of Clinical Research Affairs (OCRA) is found within the Division of Microbiology and Infectious Diseases (DMID) at the National Institute of Allergy and Infectious Diseases (NIAID). Formerly a part of Clinical Regulatory Affairs Branch (CRAB), OCRA was created in 2000 to facilitate a standardized approach to improving public health through the clinical evaluation of vaccines, biologics, and drug treatment strategies. OCRA is strategically comprised of three functional areas. These include the Clinical Group, the VTEU Program, and the Clinical Trials Management Section.
The Clinical Group is a team of medical officers and a pharmacist who have specialized clinical expertise. They provide early input in the protocol development process regarding the clinical and scientific feasibility of DMID-sponsored studies, as well as continued oversight on clinical protocol implementation.
The VTEU Program includes nurse consultants responsible for coordinating the clinical evaluation of vaccine and clinical studies performed at seven NIH-funded Vaccine and Treatment Evaluation Units (VTEUs). They coordinate clinical research activities, facilitate communication among the VTEUs and DMID, and serve as the VTEU representative within DMID.
The Clinical Trials Management Section (CTMS) is composed of nurse consultants and health specialists. The CTMS performs management, operational, and logistical functions in support of domestic and international DMID sponsored studies.
To achieve its goal, OCRA’s mission is:
back to top
Last Updated April 18, 2007