The purpose of this contract is for the continued operation of Clinical Research Products Management Center (CRPMC) to support the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS) clinical research trials networks and programs in HIV/AIDS and its comorbidities, as well as tuberculosis and hepatitis C, in the United States and international locations. The CRPMC will provide cognitive pharmaceutical services including evaluating draft protocols; reviewing site pharmacy audits, maintaining a site audit pharmacy report database; providing study product storage and stability information, guidance in research pharmacy practice and study product management activities to clinical site pharmacists; and conducting cGMP audits of manufacturing facilities. The CRPMC will provide technical expertise for the receipt of study products; storage under GMP; validate containers for the shipment of study products; evaluate orders, distribute study products; design and label of study products and product kits; package and repackage of study products under GMP; monitor product inventories and expiration dates; recall and process of study product returns, and maintain a database to track study product activities. The CRPMC will provide training in critical procedures and under limited circumstances, purchase drugs.
