University of Technology, Sydney

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96066 Clinical Trials Quality Assurance Management

6cp; 1hpw (lecture), 2hpw (workshop), on campus; availability: science students wishing to enrol in this subject as an elective must send a one-paragraph expression of interest for consideration to science.admin@uts.edu.au
There are course requisites for this subject. See access conditions.

Description

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.

Typical availability

Autumn session, City campus


Detailed subject description.

Access conditions

Note: The requisite information presented in this subject description covers only academic requisites. Full details of all enforced rules, covering both academic and admission requisites, are available at access conditions and My Student Admin.