Introduces students to quality frameworks, and associated regulatory and legal frameworks within which medical research, clinical innovation and medical device development occurs. This unit will focus on explaining quality framework rationale and requirements. Practical research and development case studies will be utilized to identify interplay between frameworks and outcomes. This unit will allow students of a broad range of backgrounds to understand the role of quality frameworks in facilitating medical research, development and management, and the central importance of concise, consistent and coherent documentation of activity within quality frameworks to occur on a regular basis.
Through semester assessment (100%)
at least 36cp of 3000-level or higher units and a WAM of 70+