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. The CRPMC will train all internal staff in critical procedures and under limited circumstances, purchase drugs.
