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What is the purpose of clinical trial monitoring?

BACKGROUND: The sources of information on clinical trial monitoring do not give information in an accessible language and do not give detailed guidance. In order to enable communication and to build clinical trial monitoring tools on a strong easily communicated foundation, we identified the need to...

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Autores principales: Love, Sharon B., Yorke-Edwards, Victoria, Ward, Elizabeth, Haydock, Rebecca, Keen, Katie, Biggs, Katie, Gopalakrishnan, Gosala, Marsh, Lucy, O’Sullivan, Lydia, Fox, Lisa, Payerne, Estelle, Hood, Kerenza, Meakin, Garry
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9526458/
https://www.ncbi.nlm.nih.gov/pubmed/36183080
http://dx.doi.org/10.1186/s13063-022-06763-2
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author Love, Sharon B.
Yorke-Edwards, Victoria
Ward, Elizabeth
Haydock, Rebecca
Keen, Katie
Biggs, Katie
Gopalakrishnan, Gosala
Marsh, Lucy
O’Sullivan, Lydia
Fox, Lisa
Payerne, Estelle
Hood, Kerenza
Meakin, Garry
author_facet Love, Sharon B.
Yorke-Edwards, Victoria
Ward, Elizabeth
Haydock, Rebecca
Keen, Katie
Biggs, Katie
Gopalakrishnan, Gosala
Marsh, Lucy
O’Sullivan, Lydia
Fox, Lisa
Payerne, Estelle
Hood, Kerenza
Meakin, Garry
author_sort Love, Sharon B.
collection PubMed
description BACKGROUND: The sources of information on clinical trial monitoring do not give information in an accessible language and do not give detailed guidance. In order to enable communication and to build clinical trial monitoring tools on a strong easily communicated foundation, we identified the need to define monitoring in accessible language. METHODS: In a three-step process, the material from sources that describe clinical trial monitoring were synthesised into principles of monitoring. A poll regarding their applicability was run at a UK national academic clinical trials monitoring meeting. RESULTS: The process derived 5 key principles of monitoring: keeping participants safe and respecting their rights, having data we can trust, making sure the trial is being run as it was meant to be, improving the way the trial is run and preventing problems before they happen. CONCLUSION: From the many sources mentioning monitoring of clinical trials, the purpose of monitoring can be summarised simply as 5 principles. These principles, given in accessible language, should form a firm basis for discussion of monitoring of clinical trials. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06763-2.
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spelling pubmed-95264582022-10-03 What is the purpose of clinical trial monitoring? Love, Sharon B. Yorke-Edwards, Victoria Ward, Elizabeth Haydock, Rebecca Keen, Katie Biggs, Katie Gopalakrishnan, Gosala Marsh, Lucy O’Sullivan, Lydia Fox, Lisa Payerne, Estelle Hood, Kerenza Meakin, Garry Trials Methodology BACKGROUND: The sources of information on clinical trial monitoring do not give information in an accessible language and do not give detailed guidance. In order to enable communication and to build clinical trial monitoring tools on a strong easily communicated foundation, we identified the need to define monitoring in accessible language. METHODS: In a three-step process, the material from sources that describe clinical trial monitoring were synthesised into principles of monitoring. A poll regarding their applicability was run at a UK national academic clinical trials monitoring meeting. RESULTS: The process derived 5 key principles of monitoring: keeping participants safe and respecting their rights, having data we can trust, making sure the trial is being run as it was meant to be, improving the way the trial is run and preventing problems before they happen. CONCLUSION: From the many sources mentioning monitoring of clinical trials, the purpose of monitoring can be summarised simply as 5 principles. These principles, given in accessible language, should form a firm basis for discussion of monitoring of clinical trials. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06763-2. BioMed Central 2022-10-01 /pmc/articles/PMC9526458/ /pubmed/36183080 http://dx.doi.org/10.1186/s13063-022-06763-2 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Methodology
Love, Sharon B.
Yorke-Edwards, Victoria
Ward, Elizabeth
Haydock, Rebecca
Keen, Katie
Biggs, Katie
Gopalakrishnan, Gosala
Marsh, Lucy
O’Sullivan, Lydia
Fox, Lisa
Payerne, Estelle
Hood, Kerenza
Meakin, Garry
What is the purpose of clinical trial monitoring?
title What is the purpose of clinical trial monitoring?
title_full What is the purpose of clinical trial monitoring?
title_fullStr What is the purpose of clinical trial monitoring?
title_full_unstemmed What is the purpose of clinical trial monitoring?
title_short What is the purpose of clinical trial monitoring?
title_sort what is the purpose of clinical trial monitoring?
topic Methodology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9526458/
https://www.ncbi.nlm.nih.gov/pubmed/36183080
http://dx.doi.org/10.1186/s13063-022-06763-2
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