修订需求:2019年《新药和临床试验规则》中的EC流程、成员培训和补偿公式。

Q2 Medicine

Perspectives in Clinical Research Pub Date : 2022-07-01 Epub Date: 2022-06-30 DOI:10.4103/picr.picr_251_21

Ravindra Bhaskar Ghooi

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引用次数: 0

摘要

新药和临床试验规则(NDCTR)于2019年生效，这些规则带来了一些变化，但某些早期部分，如规则122 DAB，没有改变。NDCTR的一些章节存在问题，需要修订，以便在印度顺利进行临床试验。伦理委员会(EC)成员和其他利益相关者的培训是临床研究的一个非常重要的驱动因素，但尚未明确定义。此外，还需要对EC审查的一些流程进行重新审视。薪酬公式于2013年定稿;现在，经济形势的变化削弱了货币的价值。因此，为了保护研究参与者，建议对补偿公式进行紧急审查。

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Need for revision: EC process, members' training, and compensation formula in the New Drugs and Clinical Trials Rules 2019.

The New Drugs and Clinical Trial Rules (NDCTR) came in force in 2019, these brought in some changes, but certain earlier parts, such as Rule 122 DAB, were incorporated unchanged. A few sections of the NDCTR are problematic and need revision for the smooth conduct of clinical trials in India. Training of Ethics Committee (EC) members and other stakeholders is a very important driver for clinical research but has not been defined clearly. In addition, some processes of EC review need a relook. Compensation formulae were finalized in 2013; now, the altered economic situation has eroded the value of money. Hence, for the protection of research participants, an urgent review of the compensation formula is suggested.

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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.