What is the purpose of clinical trial monitoring?

Abstract

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.

Metadata

Item Type:	Article
Authors/Creators:	Love, S.B. Yorke-Edwards, V. Ward, E. Haydock, R. Keen, K. Biggs, K. https://orcid.org/0000-0003-4468-7417 Gopalakrishnan, G. Marsh, L. O’Sullivan, L. Fox, L. Payerne, E. Hood, K. Meakin, G.
Copyright, Publisher and Additional Information:	© 2022 The Authors. This 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/.
Keywords:	Clinical trial monitoring; Trial conduct; Clinical trials methodology
Dates:	Published: 1 October 2022 Published (online): 1 October 2022 Accepted: 16 September 2022
Institution:	The University of Sheffield
Academic Units:	The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Health and Related Research (Sheffield) > ScHARR - Sheffield Centre for Health and Related Research
Depositing User:	Symplectic Sheffield
Date Deposited:	18 Oct 2022 08:45
Last Modified:	18 Oct 2022 08:45
Status:	Published
Publisher:	Springer Science and Business Media LLC
Refereed:	Yes
Identification Number:	10.1186/s13063-022-06763-2
Open Archives Initiative ID (OAI ID):	oai:eprints.whiterose.ac.uk:191909

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What is the purpose of clinical trial monitoring?

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