关键词: font-size:medium, ">药物临床试验质量管理规范；可疑且非预期严重不良反应；研究者；药物警戒

Abstract: Objective： To clarify the responsibility of investigators for the judgment on individual cases of suspected， unexpected serious adverse reactions (SUSAR) in clinical trial testing sites. Methods：From the attributes of SUSAR， we argued that its judgment belongs to medical ones. Based on the requirements of GCP for the qualification of investigators， we argued that investigators have the competency to judge individual SUSAR cases. From the influence of SUSAR on the rights， safety， and well-being of trial subjects， the location of the investigator in the clinical trial， and the principle of dealing with the conflict of interest， we argued that it is reasonable for the investigators to join the judgment of individual SUSAR cases. According to the relevant provisions of GCP general rules， we argued that investigators ′ judgment of individual SUSAR cases is fully compliant. Based on some other requirements of GCP for investigators， we argued that investigators have the competency to judge individual SUSAR cases is a necessary condition for carrying out. Results： Investigators and their team judge individual SUSAR cases at the site of clinical trials in line with the requirements of optimization of clinical trial procedures， in line with the principle that the rights， safety， and well-being of the subjects are the most important considerations and should prevail over the interests of science and society，in line with the principles of transparency and credibility in dealing with conflicts of interest， in line with the general rules of GCP that medical judgment or clinical decisions should always be the responsibility of a qualified physician， and is logical self-consistency with other requirements of GCP for investigators. Conclusion：The concept of SUSAR should be illuminated in the research protocol and the responsibility of the investigator to judge the cases of SUSAR at the clinical trial site should be clarified.

Key words: font-size:medium, ">Chinese Guideline for Good Clinical Practice； Suspected unexpected serious adverse reactions； Investigator； Pharmacovigilance