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Regulatory requirements for clinical trials in India: What academicians need to know
The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research. Of these, research, though long and difficult, is extremely fulfilling. Academicians often carry out research that is...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Medknow Publications & Media Pvt Ltd
2017
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5372399/ https://www.ncbi.nlm.nih.gov/pubmed/28405032 http://dx.doi.org/10.4103/ija.IJA_143_17 |
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author | Gogtay, Nithya J Ravi, Renju Thatte, Urmila M |
author_facet | Gogtay, Nithya J Ravi, Renju Thatte, Urmila M |
author_sort | Gogtay, Nithya J |
collection | PubMed |
description | The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research. Of these, research, though long and difficult, is extremely fulfilling. Academicians often carry out research that is based on observations in practice or in response to their patient's needs. These are called as “Investigator- initiated studies” and these may not have the funding support of the pharmaceutical industry. Hence, the investigator must make sure that he/she complies with the country's regulatory requirements. In the past decade, several changes have dotted the regulatory landscape in the country and have changed the way in which academic research is carried out. The present article outlines regulatory requirements for academic research giving their historical evolution, the key bodies in India that govern or oversee research, along with “must know” and “good to know” facets for the conduct of clinical research in the country. |
format | Online Article Text |
id | pubmed-5372399 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Medknow Publications & Media Pvt Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-53723992017-04-12 Regulatory requirements for clinical trials in India: What academicians need to know Gogtay, Nithya J Ravi, Renju Thatte, Urmila M Indian J Anaesth Special Article The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research. Of these, research, though long and difficult, is extremely fulfilling. Academicians often carry out research that is based on observations in practice or in response to their patient's needs. These are called as “Investigator- initiated studies” and these may not have the funding support of the pharmaceutical industry. Hence, the investigator must make sure that he/she complies with the country's regulatory requirements. In the past decade, several changes have dotted the regulatory landscape in the country and have changed the way in which academic research is carried out. The present article outlines regulatory requirements for academic research giving their historical evolution, the key bodies in India that govern or oversee research, along with “must know” and “good to know” facets for the conduct of clinical research in the country. Medknow Publications & Media Pvt Ltd 2017-03 /pmc/articles/PMC5372399/ /pubmed/28405032 http://dx.doi.org/10.4103/ija.IJA_143_17 Text en Copyright: © 2017 Indian Journal of Anaesthesia http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms. |
spellingShingle | Special Article Gogtay, Nithya J Ravi, Renju Thatte, Urmila M Regulatory requirements for clinical trials in India: What academicians need to know |
title | Regulatory requirements for clinical trials in India: What academicians need to know |
title_full | Regulatory requirements for clinical trials in India: What academicians need to know |
title_fullStr | Regulatory requirements for clinical trials in India: What academicians need to know |
title_full_unstemmed | Regulatory requirements for clinical trials in India: What academicians need to know |
title_short | Regulatory requirements for clinical trials in India: What academicians need to know |
title_sort | regulatory requirements for clinical trials in india: what academicians need to know |
topic | Special Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5372399/ https://www.ncbi.nlm.nih.gov/pubmed/28405032 http://dx.doi.org/10.4103/ija.IJA_143_17 |
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