Clinical Trial Monitoring

Guidance

Monitoring Triggers & Metrics Tool [December 2024]

Recommendations for Undertaking Greener Monitoring [August 2024]

Monitoring Access and Source Data Information Sheet to help CTU trialists confirm how monitoring access can be obtained at a participating site [June 2023]

High-level principles around the restart of on-site monitoring [June 2021]

How to move to remote monitoring with least burden to site staff – hints and tips [May 2021]

Reports & Publications

e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidence Trials 24, 657 (2023). https://doi.org/10.1186/s13063-023-07656-8 [October 2023] – As part of the e-Consent collaborative group

Monitoring advances including consent: learning from COVID-19 trials and other trials running in UKCRC registered clinical trials units during the pandemic. [Trials 22, 279 (2021). https://doi.org/10.1186/s13063-021-05225-5]

Training

Online training for staff undertaking clinical trial monitoring [April 2022]

1 – Introduction to the Principles of Monitoring

2 – On-Site Monitoring

3 – Remote Monitoring

4 – Central Monitoring

Monitoring of clinical trials: a handbook [Reissued: February 2025] NB: This guidance supersedes the version issued in December 2021

Projects from around the Network

Monitoring in practice – How are UK academic clinical trials monitored? A survey. [Trials 21, 59 (2020). https://doi.org/10.1186/s13063-019-3976-1]

Other Resources

NIHR Clinical Trials Toolkit and Routemap – Provides practical advice to researchers in designing and conducting publicly funded clinical trials in the UK.

Collaborate

The CTU Network Monitoring Operations Group is currently developing tools and guidance in a number of areas including Risk Based Monitoring. If you work within a registered CTU and would like to find out more about how to get involved in one of these ongoing projects please contact regctus@leeds.ac.uk.

Membership

For a list of current Monitoring Operations Group members please click here.

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Get in touch

If you have any questions about the site, please feel free to contact us. We are always looking for ways to better serve our members - YOU are important to us!

(0113) 3439132

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