This contract will provide pharmacological support to the DAIDS HIV/AIDS clinical trials networks. The CRPMC will provide cognitive pharmaceutical services including evaluating draft protocols and interacting with DAIDS regarding implementation issues; reviewing site pharmacy audits, and maintaining a database of these reports; providing product storage and stability information, guidance in research pharmacy practice and 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; appropriate storage under GMP criteria; validate containers for the shipment of study products under correct temperature conditions; evaluate orders for appropriateness, distribute study products to only authorized investigators with all required shipping documents; design and label study products and product kits; package and repackage study products under GMP; monitor product inventories and expiration dates; recall and process product returns, and maintain a database of product management activities.
