The candidate will understand how to effectively form, lead and successfully manage a clinical research project. The subject will address issues related to resource management (including team and finance). The key elements of putting together a solid funding application and developing a study protocol will also be covered. Specialized aspects of trial management and conduct will be presented. Issues involved in study start up (initiation), monitoring and quality assurance (including audit), and study outcome collection will be introduced. Aspects of scientific leadership including skills to address/solve problems in recruitment, follow up and event assessment will be taught. Students will gain a detailed understanding of how to plan for issues arising during a clinical trial in a practical sense including dealing with unexpected events during a trial, addressing event rates lower than that expected, changes in outcome definitions and ethical dilemmas. This is a key subject where students will gain an understanding of how to apply theory to practice.
discussion groups and problem based learning
2x quizzes (2x10%) 2x assessments (2x40%)
Recommended reading: Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.