Perspectives in Clinical Research

OPINION
Year
: 2022  |  Volume : 13  |  Issue : 3  |  Page : 129--131

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


Ravindra Bhaskar Ghooi 
 Scientia Clinical Services, Pune, Maharashtra, India

Correspondence Address:
Dr. Ravindra Bhaskar Ghooi
E 516, The Island, Wakad, Pune - 411 057, Maharashtra
India

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.


How to cite this article:
Ghooi RB. Need for revision: EC process, members' training, and compensation formula in the New Drugs and Clinical Trials Rules 2019.Perspect Clin Res 2022;13:129-131


How to cite this URL:
Ghooi RB. Need for revision: EC process, members' training, and compensation formula in the New Drugs and Clinical Trials Rules 2019. Perspect Clin Res [serial online] 2022 [cited 2022 Aug 15 ];13:129-131
Available from: http://www.picronline.org/article.asp?issn=2229-3485;year=2022;volume=13;issue=3;spage=129;epage=131;aulast=Ghooi;type=0