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A Comparative Review of ICMR, WHO, and EMA Guidelines for Good Clinical Laboratory Practices
With the advancement of clinical research and the increased burden on laboratory services, there is an unmet need for guidelines regarding proper laboratory functioning and reliable data generation. Several organizations from all over the world have published guidelines for these clinical and resear...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Thieme Medical and Scientific Publishers Pvt. Ltd.
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10264107/ https://www.ncbi.nlm.nih.gov/pubmed/37323591 http://dx.doi.org/10.1055/s-0042-1757237 |
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author | Joshi, Rajat Kumar Sarangi, Sudhir Chandra Mohapatra, Sarita Mallick, Saumyaranjan Datta, Sudip Kumar |
author_facet | Joshi, Rajat Kumar Sarangi, Sudhir Chandra Mohapatra, Sarita Mallick, Saumyaranjan Datta, Sudip Kumar |
author_sort | Joshi, Rajat Kumar |
collection | PubMed |
description | With the advancement of clinical research and the increased burden on laboratory services, there is an unmet need for guidelines regarding proper laboratory functioning and reliable data generation. Several organizations from all over the world have published guidelines for these clinical and research laboratories. Good Clinical Laboratory Practices (GCLP) are stepwise procedures aimed at strengthening the quality of test results produced by all clinical laboratories engaged in human sample analysis. In this article, we attempt a comparison of the GCLP guidelines recently issued by the Indian Council of Medical Research with the guidelines released by the World Health Organization and the European Medicines Agency. Also, we have included and discussed several suggestions that, if included, will lead to the strengthening of the laboratory practices used for both research and patient care for overall improvement in the Indian healthcare system. |
format | Online Article Text |
id | pubmed-10264107 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Thieme Medical and Scientific Publishers Pvt. Ltd. |
record_format | MEDLINE/PubMed |
spelling | pubmed-102641072023-06-15 A Comparative Review of ICMR, WHO, and EMA Guidelines for Good Clinical Laboratory Practices Joshi, Rajat Kumar Sarangi, Sudhir Chandra Mohapatra, Sarita Mallick, Saumyaranjan Datta, Sudip Kumar J Lab Physicians With the advancement of clinical research and the increased burden on laboratory services, there is an unmet need for guidelines regarding proper laboratory functioning and reliable data generation. Several organizations from all over the world have published guidelines for these clinical and research laboratories. Good Clinical Laboratory Practices (GCLP) are stepwise procedures aimed at strengthening the quality of test results produced by all clinical laboratories engaged in human sample analysis. In this article, we attempt a comparison of the GCLP guidelines recently issued by the Indian Council of Medical Research with the guidelines released by the World Health Organization and the European Medicines Agency. Also, we have included and discussed several suggestions that, if included, will lead to the strengthening of the laboratory practices used for both research and patient care for overall improvement in the Indian healthcare system. Thieme Medical and Scientific Publishers Pvt. Ltd. 2022-10-20 /pmc/articles/PMC10264107/ /pubmed/37323591 http://dx.doi.org/10.1055/s-0042-1757237 Text en The Indian Association of Laboratory Physicians. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. ( https://creativecommons.org/licenses/by-nc-nd/4.0/ ) https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License, which permits unrestricted reproduction and distribution, for non-commercial purposes only; and use and reproduction, but not distribution, of adapted material for non-commercial purposes only, provided the original work is properly cited. |
spellingShingle | Joshi, Rajat Kumar Sarangi, Sudhir Chandra Mohapatra, Sarita Mallick, Saumyaranjan Datta, Sudip Kumar A Comparative Review of ICMR, WHO, and EMA Guidelines for Good Clinical Laboratory Practices |
title | A Comparative Review of ICMR, WHO, and EMA Guidelines for Good Clinical Laboratory Practices |
title_full | A Comparative Review of ICMR, WHO, and EMA Guidelines for Good Clinical Laboratory Practices |
title_fullStr | A Comparative Review of ICMR, WHO, and EMA Guidelines for Good Clinical Laboratory Practices |
title_full_unstemmed | A Comparative Review of ICMR, WHO, and EMA Guidelines for Good Clinical Laboratory Practices |
title_short | A Comparative Review of ICMR, WHO, and EMA Guidelines for Good Clinical Laboratory Practices |
title_sort | comparative review of icmr, who, and ema guidelines for good clinical laboratory practices |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10264107/ https://www.ncbi.nlm.nih.gov/pubmed/37323591 http://dx.doi.org/10.1055/s-0042-1757237 |
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