ARM 37.106.3317. ADVERSE EVENT REPORTING

(1) Experimental treatment centers must report any serious adverse events to the department within five days. (2) An adverse event or suspected adverse reaction is considered “serious” if, in the view of the medical director, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. (3) Each report must include, at a minimum: (a) the type of experimental treatment involved; (b) the nature and severity of the adverse event; (c) the date of occurrence; (d) any corrective actions taken; and (e) information about the patient’s medical condition. (4) All adverse event data collected and reported must be reported to the experimental treatment review board and to the QAPI program pursuant to ARM 37.106.3315.