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Clinical Trial Management 18 – 22 June 2018 Rewley House, 1 Wellington Square, Oxford, UK Register at http://www.conted.ox.ac.uk/ctm Developing best practice for the management and delivery of clinical trials This module will focus on providing an understanding of the lifecycle of a clinical trial from design to publication and the key steps involved in their delivery. Students will learn about the practical steps involved in setting up and managing clinical trials. While there will be a focus on UK practice, the knowledge gained will be applicable across a number of research settings and countries, particularly those who are signatories to the ICH-GCP tripartite agreement (EU, Japan and United States, 1996). By the end of the course the student will be able to: • Appreciate the key position that randomised controlled trials play in translational research • Understand the different study designs employed by CTUs and the benefits of each • Be able to classify a clinical research study appropriately and have an understanding of the associated regulatory framework • Be able to develop a detailed trial protocol compliant with all applicable regulations • Understand the lifecycle of a clinical trial including development of detailed project plans, understanding the approvals process, the important of a statistical analysis plan, data management plan and risk based trial monitoring, and knowing how to set and monitor milestones and take corrective action • Understand the role of a Clinical Trials Unit • Have an awareness of the support available for research networks in the UK. Full details and information on how to apply can be found on the course webpage - http://www.conted.ox.ac.uk/ctm