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. Issues involved in study start up (initiation) and study outcome collection and review 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 integrate knowledge from prior studies and gain an understanding of how to apply theory to practice.
discussion groups and problem based learning
1 x Multiple-choice/short answer quiz (15%), online contribution (5%), 1 x Concept outline development and justification (3 pages) (40%), 3 x 2-page responses to scenarios (40%)
Recommended reading: Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.