中国药物警戒 ›› 2015, Vol. 12 ›› Issue (5): 302-304.

• 药械安全性研究 • 上一篇    下一篇

临床研究不良事件报告标准及报告质量探讨

李庆娜,陆芳,高蕊,   

  1. 中国中医科学院西苑医院临床药理研究所，北京 100091
  • 收稿日期:2015-01-29 发布日期:2015-06-08
  • 通讯作者: 高蕊，女，博士，主任医师·博导，中医内科学与临床中药药理。
  • 作者简介:李庆娜，女，数据管理员，硕士，临床研究数据管理与质量控制。
  • 基金资助:
    国家“重大新药创制”基金资助项目（2012ZX09303-010-002）；国家中医药管理局中医药行业科研专项基金资助项目（201107006）；中国中医科学院西苑医院苗圃课题基金资助项目 XYKY-MP(2013)-38）。

Discussion on the Reporting Standards and Quality of Adverse Events in Clinical Researches

LI Qing-na ,LU Fang GAO Rui   

  1. Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China
  • Received:2015-01-29 Published:2015-06-08

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摘要： 目的探讨临床研究不良事件的报告标准与数据质量要求。方法分析 3种情况下不良事件的报告标准，举例说明 MedDRA编码对不良事件报告原始数据的质量要求。结果 ①研究疾病的加重：研究疾病预期的自然进展不视为不良事件，除非其疾病的变化形成了新的医学诊断。②异常的实验室检查结果：异常实验室检查值只有在其伴随临床症状或体征，或需要接受医疗干预，或研究者评价具有临床意义时，才被视为不良事件。③反复出现的不良事件：转归为痊愈或消失的不良事件再次出现时，需要再报告一条 AE。④用 MedDRA字典进行编码，要求原始数据应是清晰、简洁、完整和准确的。结论在制定方案时，应对不良事件的报告标准给出尽量具体的规定，试验启动前做好相关培训，以统一报告标准，提高原始数据质量。

关键词: 临床研究, 不良事件, 报告标准, 数据质量

Abstract: Objective To discuss the reporting standards and quality of adverse events (AEs) in clinical researches. Methods The reporting standards of AEs on three occasions were analyzed and the quality requirements of the original data when coding with MedDRA terminology were illustrated. Results Aggravation of researched diseases: the natural course of diseases is not considered as AEs unless it develops intoa new diagnosis. Abnormal results of laboratory examinations: there are three occasions in which abnormal results are regarded as AEs, along with clinical symptoms or signs, the need of implementing medical intervention, clinically significant. Repeating AEs: it is necessary to report another AE once a disappeared or recovered AE happens again. The original data should be clear, concise, complete and accurate if AE terms are coded with MedDRA terminology. Conclusion The standards of AE reporting should be specified in study protocols and conduct trainings before starting a trial in order to unify the reporting standards and improve the quality of original data.

Key words: clinical research, adverse events, reporting standard, data quality

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