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. Trainin...

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Autor principal: Ghooi, Ravindra Bhaskar
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer - Medknow 2022
Materias:
Opinion
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9345253/
https://www.ncbi.nlm.nih.gov/pubmed/35928642
http://dx.doi.org/10.4103/picr.picr_251_21
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author Ghooi, Ravindra Bhaskar
author_facet Ghooi, Ravindra Bhaskar
author_sort Ghooi, Ravindra Bhaskar
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description 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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spelling pubmed-93452532022-08-03 Need for revision: EC process, members’ training, and compensation formula in the New Drugs and Clinical Trials Rules 2019 Ghooi, Ravindra Bhaskar Perspect Clin Res Opinion 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. Wolters Kluwer - Medknow 2022 2022-06-30 /pmc/articles/PMC9345253/ /pubmed/35928642 http://dx.doi.org/10.4103/picr.picr_251_21 Text en Copyright: © 2022 Perspectives in Clinical Research https://creativecommons.org/licenses/by-nc-sa/4.0/This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.
spellingShingle Opinion
Ghooi, Ravindra Bhaskar
Need for revision: EC process, members’ training, and compensation formula in the New Drugs and Clinical Trials Rules 2019
title Need for revision: EC process, members’ training, and compensation formula in the New Drugs and Clinical Trials Rules 2019
title_full Need for revision: EC process, members’ training, and compensation formula in the New Drugs and Clinical Trials Rules 2019
title_fullStr Need for revision: EC process, members’ training, and compensation formula in the New Drugs and Clinical Trials Rules 2019
title_full_unstemmed Need for revision: EC process, members’ training, and compensation formula in the New Drugs and Clinical Trials Rules 2019
title_short Need for revision: EC process, members’ training, and compensation formula in the New Drugs and Clinical Trials Rules 2019
title_sort need for revision: ec process, members’ training, and compensation formula in the new drugs and clinical trials rules 2019
topic Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9345253/
https://www.ncbi.nlm.nih.gov/pubmed/35928642
http://dx.doi.org/10.4103/picr.picr_251_21
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