96066 Clinical Trials Quality Assurance Management6cp; 1hpw (lecture), 2hpw (workshop), on campus
Requisite(s): 96057 GMP for Manufacturing Operations AND 96134 Validation Principles and Practices AND 96059 International GMPs and Quality Assurance AND 96060 Good (Quality Control) Laboratory Practices AND 96069 Contamination Control AND 96062 Good Aseptic Practices and Sterile Products AND 96063 GxP and Quality Auditing Practices AND 96064 Risk Management for Pharmaceutical Operations
There are course requisites for this subject. See access conditions.
Clinical trials are research studies on human subjects, necessary for determining the safety and effectiveness of medical treatments, devices or approaches. Such studies must adhere to strict guidelines as provided by the regulatory bodies in various regions such as Australia (Therapeutic Goods Administration), the US (Food and Drug Administration) and Europe (European Medical Agency).
This subject introduces the regulation and protocols for clinical trial programs required both nationally and globally. Clinical trial design and project management in the context of new product development is introduced. Students develop a solid understanding of clinical trial design ranging from protocols to recruitment, initiation of studies, data collection and management. It also encompasses the auditing requirements for the manufacture of clinical materials and clinical protocols.
Autumn session, City campus
Detailed subject description.