EFGCP Workshop on ‘A Practical Approach to Risk-Based Monitoring’

The specific role of the Education Working Party at EFGCP is to identify priority needs and primary challenges in the education and training of GCP among the various parties involved in preparing and carrying out clinical trials. As the multi-centre and multi-country clinical trials increase across Europe, there is a need to focus on the co-ordination and harmonisation of educational and training programs in GCP. At the same time, it is becoming more and more evident that different traditions in medical and scientific education across Europe need to be appreciated in developing GCP practices.

Over the last year several key documents have been developed globally by regulatory authorities indicating the universal trend to a risk-based monitoring approach. The regulators recognise there have been considerable advances in technology since the release of ICH GCP back in 1996. Risk management is also an area which is often poorly understood as is the use of risk management tools. Identifying risk and mitigation as well as establishing priorities and quality tolerance limits require a stratified approach. In the UK, during 2011 the MHRA have also started to look at risk-adaptive approaches in the management of clinical trials. More recently, the Commission has adopted a “Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC" ("Clinical Trials Regulation") which also needs to be considered.

The Education Working party is currently developing materials on risk-based monitoring. This potentially flexible approach to monitoring is possible especially with the use of current technologies but many have been reluctant to follow this route. It was recognised early in EFGCP’s process of developing risk-based training that despite all the discussions about adaptive monitoring, how clinical researchers should develop this approach at a practical level is less easy to understand. This new approach needs to ensure that subjects are protected on clinical trials and that data quality is not compromised. The aim of the Workshop is to interact directly with the regulators and other interested groups in order to discuss what can realistically be achieved and to define when researchers still need to follow more traditional approaches.