Researchers may find it helpful to undertake a risk assessment for their clinical trial. This can be very useful to help plan the Trial Management System and the Quality Assurance Framework because the extent of the Trial Management and level of Quality Assurance will depend on the risk of the trial. This is especially true for trial monitoring since IGH-GCP stipulates that monitoring should be proportional to the risk and complexity of the trial.
3. A useful SOP on trial monitoring including a risk assessment for determining the level of monitoring required: http://workspace.imperial.ac.uk/clinicalresearchgovernanceoffice/public/JRO%20SOP%20015%20Monitoring%20Controlled%202010.pdf
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