修订后的良好临床操作规范E6(R3)指南:原则和实践的深刻变化!

Q2 Medicine

Perspectives in Clinical Research Pub Date : 2023-01-01 DOI:10.4103/picr.picr_184_23

Arun Bhatt

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引用次数: 1

摘要

国际协调理事会发布了良好临床实践指南E6(R3)版本草案，以征求公众意见。修订指南的目标是使新的规定适用于不同的临床试验类型和环境，并随着技术和方法的进步而保持相关性。E6(R3)包括E6(R2)版本的结构和内容的深刻变化，这将影响从计划到报告的所有试验进行过程。本指南对原则、数字技术、伦理和质量的关注将增加伦理委员会、研究者和申办者的责任。这篇简短的综述讨论了该指南对审判行为的影响以及在印度实施的挑战。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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The revamped Good Clinical Practice E6(R3) guideline: Profound changes in principles and practice!

The International Council for Harmonisation has released a draft version E6(R3) of the Good Clinical Practice Guideline for public consultation. The objective of the revamped guideline is to make the new provisions applicable across diverse clinical trial types and settings and to remain relevant as technological and methodological advances occur. E6(R3) includes profound changes in the structure and content of E6(R2) version, which will impact all the trial conduct processes from planning to reporting. This guideline’s focus on principles, digital technology, ethics, and quality will increase the responsibilities of the ethics committees, the investigator, and the sponsor. This brief review discusses the impact of the guideline on trial conduct and the challenges of implementation in India.

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来源期刊

Perspectives in Clinical Research Medicine-Medicine (all)

CiteScore

2.90

自引率

0.00%

发文量

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.