摘要
目的为提高药物临床试验期间可疑且非预期严重不良反应快速报告的质量。方法以近2年监管机构收到的安全性快速报告问题为基础,结合目前国内外快速报告的相关要求及现状,筛选出共性问题。结果对我国药物临床试验期间可疑且非预期严重不良反应快速报告的几点共性问题提出分析和建议。结论从事药物临床试验期间快速报告工作的相关人员应准确理解国内外药物警戒相关的指南、法规等要求,更好地保护好受试者安全。
Objective To improve the quality of expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs. Methods This article was based on the questions of safety reports received by regulators over the past two years combined with the current requirements and developments of expedited reporting at home and, screened several common problems. Results Some common problems about expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs in China were analyzed and suggestions were offered. Conclusion Personnel engaged in expedited reporting during clinical trials of drugs should have accurate understanding of the requirements of guidelines and regulations related to pharmacovigilance at home and abroad so as to better protect the safety of subjects.
作者
刘敏
裴小静
王海学
LIU Min;PEI Xiaojing;WANG Haixue(Center for Drug Evaluation National Medical Products Administration,Beijing 102488,China)
出处
《中国药物警戒》
2022年第2期176-179,共4页
Chinese Journal of Pharmacovigilance
关键词
临床试验
快速报告
常见问题
安全性
可疑且非预期严重不良反应
clinical trials
expedited reporting
common problems
safety
suspected and unexpected serious adverse reactions
作者简介
刘敏,女,硕士,主管药师,临床试验管理;通信作者:王海学,男,博士,主任药师,临床试验管理。E-mail:wanghx@cde.org.com。
