This unit of study will cover the principles of operationalizing a clinical trial. Students will acquire the knowledge needed to conduct quality studies providing research data and to comply with Australian regulatory and ethical requirements of a clinical trial. Areas covered will include single and multi-centre trials along with the roles and responsibilities of different trial personnel and committees. Clinical trial project management including thecosts of study resources and budgets, management of recruitment and follow up, and monitoring study progress will be covered, along with the ethical and legal framework governing clinical trials. This will also include aspects of ethics approval and patient consent in various patient populations. Aspects of quality assurance in clinical trials including documentation of study procedures, clinical trial audits, and study monitoring will be discussed. The development of clinical trials reports, results and publications will also be covered.
discussion groups and problem based learning
online participation (5%); 1 x online quiz (15%), 2 x 2000 word written assignments (2 x 40%)