Unanticipated Adverse Device Effects. (UADE) and Reporting Unanticipated adverse device effects (UADE) are defined as: Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with the study device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan, Investigator’s Brochure, or package insert, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. All unanticipated adverse device effects must be reported immediately (within 24 hours of knowledge of the event) to the study Sponsor. The Investigator must submit to the sponsor and to the reviewing IRB a written report as soon as possible, but in no event later than 5 working days after the Investigator first learns of the event. A sponsor who conducts an evaluation of a UADE under CFR 812.46(b) shall report the results of such evaluation to FDA and to all reviewing IRBs and participating investigators within 10 working days after the sponsor first receives notice of the effect. Thereafter the sponsor shall submit such additional reports concerning the effect as FDA requests. A sponsor who determines that a UADE presents an unreasonable risk to subjects shall terminate all investigations or parts of investigations presenting that risk as soon as possible. Termination shall occur not later than 5 working days after the sponsor makes this determination and not later than 15 working days after the sponsor first received notice of the effect.
Unanticipated Adverse Device Effects. The sponsor shall report the result of such evaluations to FDA and to all reviewing IRB’s and participating Investigators within 10 working days after the sponsor first receives notice of the effect.
Unanticipated Adverse Device Effects. MRK shall have sole and full responsibility for surveillance, identification and documentation of any suspected, observed or reported Unanticipated Adverse Device Effects in Clinical Trial Subjects.
Unanticipated Adverse Device Effects. (EVENTS) An unanticipated adverse device effect is defined as “any serious adverse effect on health or safety, or any life- threatening problem, or death caused by, or associated with, a device; if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan, or application (including supplementary application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.” If an unanticipated adverse device effect occurs, the investigator should notify the Sponsor as soon as possible of such an event. The investigator must promptly notify the reviewing IRB OR EC of such an event as soon as possible, but no later than 10 working days after learning of the event.
