N.D. Admin. Code 61-07-01-12
Investigational drugs must be properly labeled and may be administered only under the personal and direct supervision of the principal physician-investigator or physician-investigator's authorized clinician with prior approval of the appropriate committees of the hospital. Nurses may administer such drugs only after they have been educated and trained concerning relevant pharmacologic information about such drugs by the clinician or the pharmacist. A central unit must be maintained wherein essential information regarding such drugs may be obtained. Patients' or representatives' informed consent must be obtained prior to investigational drug therapy. Investigational drugs must be stored under the same regulations as Schedule II controlled substances.
N.D. Admin Code 61-07-01-12
General Authority: NDCC 28-32-02
Law Implemented: NDCC 43-15-10(9), 43-15-10(12), 43-15-10(14)