Procedures for handling adverse events in clinical trials of medical devices

    Adverse events (AE) refer to unfavorable medical events that occur during clinical trials, regardless of whether they are related to experimental medical devices.

    A serious adverse event (SAE) refers to a death or serious deterioration in health that occurs during a clinical trial, including fatal diseases or injuries, permanent defects in body structure or body function, requiring hospitalization or prolonged hospitalization, and the need to undergo Medical or surgical intervention to avoid permanent defects in body structure or body functions; events such as fetal distress, fetal death, or congenital abnormalities or congenital defects.

In the event of an adverse event, the event should first be effectively resolved, adequate and timely treatment and treatment should be provided to the subject, to avoid or reduce the harm caused by the adverse event to the subject, and to ensure the rights and interests of the subject; when the subject has a concurrent disease When treatment and treatment are needed, the researcher should inform the subject in time.

    When unanticipated adverse events are discovered during the trial, the investigator and the sponsor should jointly modify the relevant content of the informed consent form and send it to the ethics committee for review. After review and approval, the subject will re-sign and confirm the informed consent form.

    When a serious adverse event occurs, the investigator should report in writing to the clinical trial institution to which it belongs, and notify the sponsor in writing; the sponsor should report to the registered drug supervision and administration department and the health and family planning department at the same level within 5 working days after being notified. Report, and report to other clinical trial institutions and researchers that cannibalize the trial; at the same time, the medical device clinical trial management department should report in writing to the corresponding ethics committee, the local drug supervision and management department and the health and family planning department within 24 hours. For deaths, clinical trial institutions and researchers should provide all necessary information to the ethics committee and sponsors.

    Adverse events and device defects discovered in the course of clinical trials should be recorded by the investigator and analyzed together with the sponsor, and a written report should be formed, and opinions on continuation, suspension or termination of the trial should be put forward, and the clinical trial management of medical devices by the clinical trial institution The department reports to the ethics committee for review. In addition, the inspector should confirm that all adverse events are recorded, and serious adverse events should be reported and recorded within the specified time.