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Investigator preparedness for monitoring and audits

Monitoring and audits are two distinct processes that ensure that the rights and safety of the participants are protected, and data integrity is maintained. The present narrative summates authors' experiences with monitoring and audits by sponsor along with challenges faced by the site. It also...

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Autores principales: Ravi, Renju, Bose, Debdipta, Gogtay, Nithya J., Thatte, Urmila M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5950617/
https://www.ncbi.nlm.nih.gov/pubmed/29862203
http://dx.doi.org/10.4103/picr.PICR_42_18
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author Ravi, Renju
Bose, Debdipta
Gogtay, Nithya J.
Thatte, Urmila M.
author_facet Ravi, Renju
Bose, Debdipta
Gogtay, Nithya J.
Thatte, Urmila M.
author_sort Ravi, Renju
collection PubMed
description Monitoring and audits are two distinct processes that ensure that the rights and safety of the participants are protected, and data integrity is maintained. The present narrative summates authors' experiences with monitoring and audits by sponsor along with challenges faced by the site. It also offers potential solutions for challenges faced during the process of monitoring and audits. It is important to remember that no monitoring or audit can ever substitute for a well-designed and articulated protocol. In addition, a determined approach by the investigator and his/her team to ensure that all aspects of the protocol are adhered to in totality will go a long way in assuring quality.
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spelling pubmed-59506172018-06-01 Investigator preparedness for monitoring and audits Ravi, Renju Bose, Debdipta Gogtay, Nithya J. Thatte, Urmila M. Perspect Clin Res Investigator Insights Monitoring and audits are two distinct processes that ensure that the rights and safety of the participants are protected, and data integrity is maintained. The present narrative summates authors' experiences with monitoring and audits by sponsor along with challenges faced by the site. It also offers potential solutions for challenges faced during the process of monitoring and audits. It is important to remember that no monitoring or audit can ever substitute for a well-designed and articulated protocol. In addition, a determined approach by the investigator and his/her team to ensure that all aspects of the protocol are adhered to in totality will go a long way in assuring quality. Medknow Publications & Media Pvt Ltd 2018 /pmc/articles/PMC5950617/ /pubmed/29862203 http://dx.doi.org/10.4103/picr.PICR_42_18 Text en Copyright: © 2018 Perspectives in Clinical Research http://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 Investigator Insights
Ravi, Renju
Bose, Debdipta
Gogtay, Nithya J.
Thatte, Urmila M.
Investigator preparedness for monitoring and audits
title Investigator preparedness for monitoring and audits
title_full Investigator preparedness for monitoring and audits
title_fullStr Investigator preparedness for monitoring and audits
title_full_unstemmed Investigator preparedness for monitoring and audits
title_short Investigator preparedness for monitoring and audits
title_sort investigator preparedness for monitoring and audits
topic Investigator Insights
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5950617/
https://www.ncbi.nlm.nih.gov/pubmed/29862203
http://dx.doi.org/10.4103/picr.PICR_42_18
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