Abstract: Objective To give advice about drug safety during clinical trials by introducing ways to manage adverse events(AE). Methods By summarizing the laws and regulations in China, reviewing the related literature, and outlining the sponsors' current practices, the time and ways to collect AE, the content to be collected, means of reporting of safety information and analysis of reports of AE were described. Results With the successive enforcement of laws and regulations in China, the collection and reporting of adverse events during clinical trials became increasingly standardized, but there was still a lack of uniform standards in some specific areas (e.g. start-end time or causality judgment). Conclusion Management of safety in clinical trials underlies the establishment of safety profiles in the product label as well as post-marketing safety surveillance. Therefore, close collaboration and active communication between health authorities, sponsors, and investigators are critical.

Key words: clinical trial, adverse event, collection, management, safety, pharmacovigilance