Note Administration of investigational medications shall be performed in accordance with Fairview Hospital and Healthcare Services Investigational Drug Policy . The Academic Health Center strongly encourages an investigator to use the services of the pharmacy at the institution where the inpatients will be seen. If the pharmacy at the institution serving as the site for the inpatient study is not coordinating the control of the research drug, as outlined in the previous section, 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.