ARM 37.106.3308. MEDICAL DIRECTOR

(1) An experimental treatment center must have a medical director who has a current physician license in good standing with the Montana Board of Medical Examiners. (2) The medical director is responsible for: (a) overseeing treatment delivered in the center; (b) developing and maintaining a comprehensive system that tracks all experimental treatments conducted at the center, including patient outcomes for each treatment and the current Food and Drug Administration (FDA) approval status of each; and (c) overseeing the performance of the medical staff. (3) The medical director must participate in establishing competency criteria for medical personnel, including training in procedures performed at the center. (4) The medical director must ensure that treatments are compliant with 50-12-102(1), MCA. (5) The medical director may also serve as the experimental treatment center administrator. (6) The medical director may provide oversight to multiple experimental treatment centers, provided that: (a) each center is owned and operated by the same legal entity; (b) each center maintains a written agreement with the medical director defining specific responsibilities; (c) the medical director can demonstrate adequate availability and oversight capacity for each center; and (d) each center meets all applicable standards under these rules. (7) The medical director serves as the center’s safety officer and is responsible for overseeing the center’s safety program. (8) The medical director has the responsibility of the infection control officer, ensuring that the infection control program meets all requirements of ARM 37.106.3318. (a) The medical director may delegate this responsibility to another practitioner who, given the clinical risks and oversight demands, is qualified to serve as the infection control officer.