MHRA GCP Symposium

Joanna Black attended the 2014 annual MHRA GCP symposium on the 11th Feb, where the majority of talks were delivered by the MHRA GCP Inspectors. The theme for the symposium revolved around electronic Trial Master Files, the pros and cons of using electronic systems and the need for quality control and validation of any electronic system used. The day continued with talks on electronic medical notes, electronic Case Report Forms (CRFs) and electronic source data and the challenges around access. There was an update about the proposal from the Health Research Authority (HRA) with the HRA proposing to do the ethics and R&D approvals so that site approval by R&D can focus mainly on capacity and capability thus avoiding the duplication of checks. There was a session on common Inspection Findings, looking at metrics of GCP inspections conducted from April 2011 to March 2012. The day finished with a talk by Martyn Ward, head of the MHRA Clinical Trials Unit with an update of the Regulation on Clinical Trials (likely to be published June-July 2014) and how this will repeal the current Clinical Trials Directive. It was nice to see how much of an involvement the MHRA had had to shape the new Regulation and to introduce a risk based approach to the management and monitoring of clinical trials, based on UK experience. The whole event was extremely well attended and as always it was a real pleasure to listen to the talks and have an opportunity to network with other people and be able to talk to the inspectors who were available during the day. OCTRU are planning to run a session on the eTMF talk.