严重不良事件报告分析:由三级医疗教学医院机构伦理委员会审查。

Q2 Medicine
Perspectives in Clinical Research Pub Date : 2022-10-01 Epub Date: 2021-07-12 DOI:10.4103/picr.PICR_293_20
Ganesh Nathuji Dakhale, Mrunalini Vinay Kalikar, Akhil B Giradkar, Vishakha V Sinha
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引用次数: 0

摘要

背景:在临床试验中,所有利益相关者(即主要研究者(PI)、发起人和机构伦理委员会(IEC))以道德的方式管理SAE是参与者安全的最重要指标。本研究的目的是评估报告SAEs的合规性程度、相关性以及各利益相关者给出/建议的财务补偿。方法:这是一项回顾性观察性研究,涉及IEC审查的SAE分析。取得了查阅文件的行政批准,并保持了完全保密。我们对2014年1月至2020年3月报告的34项监管性临床试验中的66项SAE进行了分析。结果:分析相关性时,16例(24.24%)报告的SAE与临床试验相关,其中7例为死亡SAE。其余50例SAEs中,48例(72.7%)与临床试验无关。65例(98.48%)SAEs的初始报告和最终报告均在规定时间内向EC提交。所有66份SAE报告均在规定时间内由EC按规定发送。结论:该研究得出了66份SAE报告,在65份SAE报告中,PI的初始报告和应有的分析报告以及IEC的初始审查报告的报告时间表没有偏差。同样,通过IEC对SAE的相关性进行分析,并向参与者提供补偿,在大多数SAE中都实现了。该研究的独特之处在于对SAE报告进行了定性和定量分析。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Analysis of serious adverse events reports: Review by an Institutional Ethics Committee of a tertiary care teaching hospital.

Analysis of serious adverse events reports: Review by an Institutional Ethics Committee of a tertiary care teaching hospital.

Background: Managing of SAE by all stakeholders i.e. principal investigator (PI), sponsor, and Institutional Ethics Committee (IEC), in an ethical manner is the most important indicator of participant safety during clinical trial. The present study was conducted with the objectives to assess the extent of regulatory compliance in reporting SAEs, relatedness and financial compensation given/recommended by various stakeholders.

Methods: This was a retrospective observational study which involved analysis of SAE's reviewed by IEC. Administrative approval for accessing the documents was obtained and complete confidentiality was maintained. A total of 66 SAE of 34 regulatory clinical trials reported from January 2014 to March 2020 were analyzed.

Result: When analyzed for relatedness, 16 (24.24%) of the reported SAEs were found related to the clinical trial and out of these, 7 were SAE of death. Among the remaining 50 SAEs, 48 (72.7 %) were not related to clinical trial .65 (98.48%) SAEs, initial report and final report were submitted to EC within timelines. All the 66 SAE reports were sent by EC within stipulated time as required by regulation.

Conclusion: The study concludes that 66 SAE reports were identified and there was no deviation in reporting timelines in initial reporting and due analysis report by PI and initial review by IEC in 65 SAE's. Similarly, analysis of SAE by IEC for relatedness, and provision of compensation to participant was achieved in majority of SAE. The study is unique in a way that qualitative and quantitative analysis of SAE reports was performed.

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来源期刊
Perspectives in Clinical Research
Perspectives in Clinical Research Medicine-Medicine (all)
CiteScore
2.90
自引率
0.00%
发文量
41
审稿时长
36 weeks
期刊介绍: This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.
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