上市前藥物和醫(yī)療器械安全性信息主要來自臨床試驗，而觀察受試者對試驗藥物和器械反應(yīng)的是研究者，因此，研究者的不良事件報告至關(guān)重要。為幫助研究者確認(rèn)臨床研究期間非預(yù)期的安全性信息并遵守安全性報告要求，美國食品藥品管理局（FDA）于2021年9月發(fā)布了“研究者職責(zé)-研究性藥物和器械的安全性報告”指導(dǎo)原則（草案），詳細(xì)說明了對研究者在IND和IDE研究中向申請人和倫理委員會報告的要求。我國目前還沒有類似的指導(dǎo)原則，詳細(xì)介紹FDA的該指導(dǎo)原則，以期對我國新藥和新醫(yī)療器械研究者在臨床研究期間識別非預(yù)期的安全信息并按要求及時報告有幫助并對該方面的監(jiān)管有所啟示。

The safety information of drugs and medical devices prior to marketing mainly comes from clinical trials, and it is the investigators who observe the subjects' responses to the investigational drugs and devices. Therefore, adverse event reports from investigators are critically important. To help investigators identify unanticipated safety information during clinical investigation and comply with safety reporting requirements, FDA issued the Investigator Responsibilities-Safety Reporting for Investigational Drugs and Devices Guidance for Industry (Draft) in September 2021.The requirements for investigators to report to the sponsors and instituttional review boards in IND and IDE studies are described in detail. At present, there is no similar guidance in China. The guidance of FDA is introduced in detail, which is expected to be helpful for Chinese investigators of new drugs and new medical devices to identify unanticipated safety information during clinical research and report it in time as required, and also to enlighten China's supervision in this regard.

R951