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The future of monitoring in clinical research – a holistic approach: Linking risk-based monitoring with quality management principles
Since several years risk-based monitoring is the new “magic bullet” for improvement in clinical research. Lots of authors in clinical research ranging from industry and academia to authorities are keen on demonstrating better monitoring-efficiency by reducing monitoring visits, monitoring time on si...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
German Medical Science GMS Publishing House
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3563312/ https://www.ncbi.nlm.nih.gov/pubmed/23382708 http://dx.doi.org/10.3205/000172 |
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author | Ansmann, Eva B. Hecht, Arthur Henn, Doris K. Leptien, Sabine Stelzer, Hans Günther |
author_facet | Ansmann, Eva B. Hecht, Arthur Henn, Doris K. Leptien, Sabine Stelzer, Hans Günther |
author_sort | Ansmann, Eva B. |
collection | PubMed |
description | Since several years risk-based monitoring is the new “magic bullet” for improvement in clinical research. Lots of authors in clinical research ranging from industry and academia to authorities are keen on demonstrating better monitoring-efficiency by reducing monitoring visits, monitoring time on site, monitoring costs and so on, always arguing with the use of risk-based monitoring principles. Mostly forgotten is the fact, that the use of risk-based monitoring is only adequate if all mandatory prerequisites at site and for the monitor and the sponsor are fulfilled. Based on the relevant chapter in ICH GCP (International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use – Good Clinical Practice) this publication takes a holistic approach by identifying and describing the requirements for future monitoring and the use of risk-based monitoring. As the authors are operational managers as well as QA (Quality Assurance) experts, both aspects are represented to come up with efficient and qualitative ways of future monitoring according to ICH GCP. |
format | Online Article Text |
id | pubmed-3563312 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | German Medical Science GMS Publishing House |
record_format | MEDLINE/PubMed |
spelling | pubmed-35633122013-02-04 The future of monitoring in clinical research – a holistic approach: Linking risk-based monitoring with quality management principles Ansmann, Eva B. Hecht, Arthur Henn, Doris K. Leptien, Sabine Stelzer, Hans Günther Ger Med Sci Article Since several years risk-based monitoring is the new “magic bullet” for improvement in clinical research. Lots of authors in clinical research ranging from industry and academia to authorities are keen on demonstrating better monitoring-efficiency by reducing monitoring visits, monitoring time on site, monitoring costs and so on, always arguing with the use of risk-based monitoring principles. Mostly forgotten is the fact, that the use of risk-based monitoring is only adequate if all mandatory prerequisites at site and for the monitor and the sponsor are fulfilled. Based on the relevant chapter in ICH GCP (International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use – Good Clinical Practice) this publication takes a holistic approach by identifying and describing the requirements for future monitoring and the use of risk-based monitoring. As the authors are operational managers as well as QA (Quality Assurance) experts, both aspects are represented to come up with efficient and qualitative ways of future monitoring according to ICH GCP. German Medical Science GMS Publishing House 2013-02-04 /pmc/articles/PMC3563312/ /pubmed/23382708 http://dx.doi.org/10.3205/000172 Text en Copyright © 2013 Ansmann et al. http://creativecommons.org/licenses/by-nc-nd/3.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/). You are free to copy, distribute and transmit the work, provided the original author and source are credited. |
spellingShingle | Article Ansmann, Eva B. Hecht, Arthur Henn, Doris K. Leptien, Sabine Stelzer, Hans Günther The future of monitoring in clinical research – a holistic approach: Linking risk-based monitoring with quality management principles |
title | The future of monitoring in clinical research – a holistic approach: Linking risk-based monitoring with quality management principles |
title_full | The future of monitoring in clinical research – a holistic approach: Linking risk-based monitoring with quality management principles |
title_fullStr | The future of monitoring in clinical research – a holistic approach: Linking risk-based monitoring with quality management principles |
title_full_unstemmed | The future of monitoring in clinical research – a holistic approach: Linking risk-based monitoring with quality management principles |
title_short | The future of monitoring in clinical research – a holistic approach: Linking risk-based monitoring with quality management principles |
title_sort | future of monitoring in clinical research – a holistic approach: linking risk-based monitoring with quality management principles |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3563312/ https://www.ncbi.nlm.nih.gov/pubmed/23382708 http://dx.doi.org/10.3205/000172 |
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