The Clinical Agents Repository Program supports the work of the Office of Regulatory Affairs (ORA), in the Division of Microbiology and Infectious Diseases (DMID). ORA provides regulatory oversight in the conduct of human subjects research funded by DMID and ensures compliance with federal regulations and policies as well as National Institutes of Health, NIAID, and DMID policies.
The program maintains a repository of investigational products (therapeutics, drugs, and vaccines), and clinical trial-related supplies (thermometers, syringes, etc.) for use by investigators conducting DMID-sponsored clinical trials. The repository also facilitates shipment of clinical specimens from DMID-funded clinical research sites to testing laboratories. Recipients of investigational products and biological samples must complete requisite Good Clinical Practice training and must follow any and all relevant CFR rules and regulations. ORA staff work collaboratively with program staff responsible for scientific oversight of the trials and the Office of Clinical Research Affairs, which has responsibility for monitoring the conduct of clinical research.