- Posted By: Joanna Black
Earlier in September I attended the annual MHRA GCP one day symposium where the agenda focused on the following activities:
• Oversight – Trial and System Design
• Oversight of IMP Management and Interactive Response Technology
• Maintaining the Blind and unblinding issues
• Data Integrity Controls
• Monitoring and Oversight of Monitoring
• Monitoring at Sites
There were nine speakers ranging from Expert Senior GCP and GLP Inspectors, Medical Assessors and Operations Managers bringing together two of the MHRA Divisions: Inspectorate Division and the Clinical Trials Unit. All of the presentations are available on request from OCTRU HoRAQ (Joanna Black).
As a result of the symposium OCTRU are re-visiting the SOPs on Monitoring and Risk Assessment and we will address any gaps if deemed necessary. The day offered the opportunity to do a workshop on Monitoring Findings. It was good to see that the MHRA fully endorse the Risk Proportionate Approach to Monitoring based on the MRC/DOH/MHRA model issued in 2011 and which OCTRU have also adopted as a model to plan monitoring.