Handbook on Monitoring of clinical trials launched
03 Dec 2021
We are delighted to announce the launch of the ‘UKCRC Registered CTU Network – Monitoring of clinical trials: a handbook’. The handbook has been developed by the UK Clinical Research Collaboration Task and Finish Monitoring Group with the assistance of staff from clinical trials units, including the MRC Clinical Trials Unit at UCL.
Clinical trial monitoring is checking that the rights and well-being of the participants are being respected, that participants are safe, that there is data integrity (i.e., the data is what it should be) and trial integrity (i.e., the trial is being run as per the protocol). It is a fundamental part of running a clinical trial in order to obtain trial results that you can trust. Regulators and the “International Council for Harmonisation of technical requirements for pharmaceuticals for human use” (ICH) have published high level aims for clinical trial monitoring. Leading on from the published aims, this handbook gives practical guidance on how to conduct monitoring for your trial.
The monitoring handbook is aimed at UK academic trialists undertaking monitoring activities such as on-site, remote and central monitoring. It is intended to be used as a resource to support initial training of those performing monitoring activities and as a point of reference thereafter. The handbook provides general information about monitoring, which should be supported by training on CTU/Sponsor specific SOPs, guidance documents and templates. This handbook provides information on the theory of monitoring, tips on conduct and real-life examples and exercises that may help to explain and support possible monitoring approaches and their application.