Exploration of the ethical review mechanism of serious adverse events in hospital clinical trials

Abstract

Objective To continuingly update the ethical review mechanism of Serious Adverse Events(SAE) in hospital clinical trials. Methods The definition of serious adverse events and the status quo of SAE review was analyzed, considering the standard operating procedures of SAE review in our hospital, as well as related measurements for improvement. Results At present, there still exists some disadvantages in the report and ethical review of SAE, which the ethical review committee should pay more attention. Conclusions It is important that the ethics committee review of SAE happened in clinical trial effectively and efficiently, which helps to maximize the protection of the subject's health and rights. Key words: Clinical trials; Subjects; Ethical review committee; Serious adverse events; Standard operating procedures