International Council for Harmonisation E6(R2) addendum: Challenges of implementation

The International Council for Harmonisation (ICH) E6 – good clinical practice (GCP) (R2) addendum – was released in 2016 to encourage implementation of improved approaches for the management of clinical trials. The changes in different sections include new approaches – quality management system, ris...

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Autor principal: Bhatt, Arun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2017
Materias:
Opinion
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5654214/
https://www.ncbi.nlm.nih.gov/pubmed/29109932
http://dx.doi.org/10.4103/picr.PICR_124_17
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author Bhatt, Arun
author_facet Bhatt, Arun
author_sort Bhatt, Arun
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description The International Council for Harmonisation (ICH) E6 – good clinical practice (GCP) (R2) addendum – was released in 2016 to encourage implementation of improved approaches for the management of clinical trials. The changes in different sections include new approaches – quality management system, risk-based monitoring with emphasis on human subject protection, and data integrity. The article discusses challenges in adoption and implementation of the changes in ICH GCP guideline for clinical trial stakeholders.
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spelling pubmed-56542142017-11-06 International Council for Harmonisation E6(R2) addendum: Challenges of implementation Bhatt, Arun Perspect Clin Res Opinion The International Council for Harmonisation (ICH) E6 – good clinical practice (GCP) (R2) addendum – was released in 2016 to encourage implementation of improved approaches for the management of clinical trials. The changes in different sections include new approaches – quality management system, risk-based monitoring with emphasis on human subject protection, and data integrity. The article discusses challenges in adoption and implementation of the changes in ICH GCP guideline for clinical trial stakeholders. Medknow Publications & Media Pvt Ltd 2017 /pmc/articles/PMC5654214/ /pubmed/29109932 http://dx.doi.org/10.4103/picr.PICR_124_17 Text en Copyright: © 2017 Perspectives in Clinical Research 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 Opinion
Bhatt, Arun
International Council for Harmonisation E6(R2) addendum: Challenges of implementation
title International Council for Harmonisation E6(R2) addendum: Challenges of implementation
title_full International Council for Harmonisation E6(R2) addendum: Challenges of implementation
title_fullStr International Council for Harmonisation E6(R2) addendum: Challenges of implementation
title_full_unstemmed International Council for Harmonisation E6(R2) addendum: Challenges of implementation
title_short International Council for Harmonisation E6(R2) addendum: Challenges of implementation
title_sort international council for harmonisation e6(r2) addendum: challenges of implementation
topic Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5654214/
https://www.ncbi.nlm.nih.gov/pubmed/29109932
http://dx.doi.org/10.4103/picr.PICR_124_17
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