What is the purpose of clinical trial monitoring?

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 moni...

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Published inCurrent controlled trials in cardiovascular medicine Vol. 23; no. 1; p. 836
Main Authors 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
Format Journal Article
LanguageEnglish
Published England BioMed Central Ltd 01.10.2022
BioMed Central
BMC
Subjects
Clinical trial monitoring
Clinical trials
Clinical Trials as Topic
Clinical trials methodology
Communication
Evaluation
FDA approval
Humans
Information management
Medical equipment
Medical research
Methodology
Pharmaceutical industry
Principles
R&D
Research & development
Trial conduct
Trust
United Kingdom
United Kingdom > UK
United States > US
Clinical trials methodology
Clinical trial monitoring
Trial conduct
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Summary: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. 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. 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. 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.
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ISSN:1745-6215
1745-6215
DOI:10.1186/s13063-022-06763-2