中国药物警戒 ›› 2018, Vol. 15 ›› Issue (11): 693-695.

• 安全性评价与合理用药 • 上一篇    下一篇

药物临床试验机构质控中不良事件记录存在问题分析

曾玲, 潘霞云   

  1. 常德市第一人民医院,湖南 常德 415000
  • 收稿日期:2019-01-09 修回日期:2019-01-09 出版日期:2018-11-20 发布日期:2019-01-09
  • 作者简介:曾玲,女,硕士,副主任药师,药物临床试验及临床药学。

Analysis of Adverse Event Records in Quality Control of Drug Clinical Trial Institutions

ZENG Ling, PAN Xiayun   

  1. First People's Hospital of Changde City, Hunan Changde 415000, China
  • Received:2019-01-09 Revised:2019-01-09 Online:2018-11-20 Published:2019-01-09

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摘要： 目的 探讨并分析机构质控中发现的不良事件记录存在的问题。方法 收集本机构2017—2018年进行的19项临床试验项目机构质控报告中不良事件记录、处理和报告情况,并进行分析。结果 不良事件记录存在的问题包括不良事件漏记、不良事件与试验药物因果关系判定不清、不良事件记录不完整、SAE获知时间滞后等。产生上述问题的原因有研究者GCP意识不强,对不良事件理解和重视程度不够,培训与宣教不到位等。结论 不良事件记录容易出现质量问题,研究者应引起高度重视,临床试验各方应加强不良事件的监管,共同提升项目质量和水平。

关键词: 药物临床试验, 机构质控, 不良事件

Abstract: Objective To explore and analyze the adverse event record problems in quality control of drug clinical trial institutions. Methods The records, treatment and reports of adverse events in the quality control reports of 19 clinical trial projects conducted in the institution from 2017 to 2018 were collected and analyzed. Results Problems include omission of adverse events, unclear determination of causality between adverse events and trial drugs, incomplete records of adverse events, and delayed SAE learning time. The reasons for the above problems include the researchers' weak awareness of GCP, insufficient understanding and attention to adverse events, and insufficient training and subject education. Conclusion The records of adverse events are easy to cause quality problems, researchers should attach great importance to them. All parties involved in clinical trials should strengthen the supervision of adverse events and jointly improve the quality and level of the project.

Key words: drug clinical trials, quality control, adverse events

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