Clinical Agents and Specimen Repository
About
What services does this resource provide?
The Clinical Agent and Specimen Repository Program provides services to support 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 NIH, NIAID, and DMID policies.
The Program maintains a repository of investigational products (therapeutics, drugs and vaccines), biological specimens, and clinical trial-related supplies (thermometers, syringes, etc) for use by investigators conducting DMID-sponsored clinical trials. Recipients of investigational products and biological samples must complete requisite Good Clinical Practice (GCP) 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 (OCRA), which has responsibility for monitoring the conduct of clinical research.
Where are the services provided?
Services are provided by Fisher BioServices (non-Government link).
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