Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit

Smith, Catrin Tudur and Williamson, Paula and Jones, Ashley and Smyth, Alan R. and Hewer, Simon Langton and Gamble, Carrol (2014) Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit. Trials, 15 (127). ISSN 1745-6215

PDF (Smith Trials 2014 Risk proportionate monitoring) - Requires a PDF viewer such as GSview, Xpdf or Adobe Acrobat Reader
Available under Licence Creative Commons Attribution.
Download (906kB) | Preview



Some level of monitoring is usually required during a clinical trial to protect the rights and safety of trial participants and to safeguard the quality and reliability of trial results. Although there is increasing support for the use of risk-proportionate approaches to achieve these aims, the variety of methods and lack of an empirical evidence base can present challenges for clinical trial practitioners.


This paper describes the monitoring methods and procedures that are utilised by a noncommercial clinical trials unit which coordinates a range of clinical trials across a variety of clinical areas with different associated risks.


Monitoring activities and approaches should be selected to be proportionate to the risks identified within a trial. A risk-proportionate approach to monitoring is described giving details of methods that may be considered by clinical trial practitioners during the development of a trial monitoring plan. An example risk assessment and corresponding monitoring plan for a low risk (type A in the Medicines and Healthcare Products Regulatory Agency (MHRA) classification system) pediatric trial is provided for illustration.


We present ideas for developing a monitoring plan for a clinical trial of an investigational medicinal product based on our experience. Alternative approaches may be relevant or preferable in other settings based on inherent risk.

Item Type: Article
Keywords: Monitoring, Central monitoring, On-site monitoring, Risk proportionate, Quality assurance
Schools/Departments: University of Nottingham UK Campus > Faculty of Medicine and Health Sciences > School of Medicine > Division of Child Health, Obstetrics and Gynaecology
Identification Number: https://doi.org/10.1186/1745-6215-15-127
Depositing User: Smyth, Prof Alan
Date Deposited: 15 Feb 2016 09:23
Last Modified: 14 Sep 2016 17:27
URI: http://eprints.nottingham.ac.uk/id/eprint/31675

Actions (Archive Staff Only)

Edit View Edit View