Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Oct 1;23(1):836.
doi: 10.1186/s13063-022-06763-2.

What is the purpose of clinical trial monitoring?

Sharon B Love  1 , Victoria Yorke-Edwards  2 , Elizabeth Ward  3 , Rebecca Haydock  4 , Katie Keen  5 , Katie Biggs  6 , Gosala Gopalakrishnan  7 , Lucy Marsh  8 , Lydia O'Sullivan  9 , Lisa Fox  10 , Estelle Payerne  11 , Kerenza Hood  12 , Garry Meakin  4
Affiliations

What is the purpose of clinical trial monitoring?

Sharon B Love et al. Trials. .

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.

Keywords: Clinical trial monitoring; Clinical trials methodology; Trial conduct.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

References

    1. ICH . International Conference on Harmonisation of technical requirements for pharmaceuticals for human use (ICH). Guideline for good clinical practice E6(R2) 2018. 1996.
    1. Houston L, Martin A, Yu P, et al. Time-consuming and expensive data quality monitoring procedures persist in clinical trials: a national survey. Contemp Clin Trials. 2021;103:106290. doi: 10.1016/j.cct.2021.106290. - DOI - PubMed
    1. Medicines for human use (clinical trials) (amendment) (EU exit) regulations 2019. 2019. https://www.legislation.gov.uk/uksi/2019/744/contents. Accessed 5 Oct 2021.
    1. Beever D, Swaby L. An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units. Trials. 2019;20:556. doi: 10.1186/s13063-019-3619-6. - DOI - PMC - PubMed
    1. Love SB, Yorke-Edwards V, Lensen S, et al. Monitoring in practice - how are UK academic clinical trials monitored? A survey. Trials. 2020;21:59. doi: 10.1186/s13063-019-3976-1. - DOI - PMC - PubMed