As the coordinating and control center, the FUMC Investigational Drug Service assumes the responsibility for maintaining records of the drugs delivered to the FUMC Investigational Drug Service, inventory of the drug, dispensing of drugs to research subjects, and the return to the sponsor or disposition of unused product. The FUMC Investigational Drug Service will store and dispense the investigational drug as specified by the sponsor and in accordance with applicable regulatory requirements. If the FUMC Investigational Drug Service is not coordinating the control of the research drug, as outlined in the above paragraph, then the principal investigator is responsible for the control of the drug. The investigator must maintain records of the product's delivery to the study site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused product. Storage area can be locked.
Investigational drug is stored separately from other compounds.
Non-dispensed drug is stored separately from returned dispensed drug. Inventory control procedures are used. Any environmental controls are maintained. Access is limited to study staff. According to the Minnesota Statutes and Rules, only a licensed practitioner or pharmacist is authorized to compound or dispense legend drugs.