This Course will introduce investigators to:

• The Australian regulatory requirements governing clinical trials 
• The impact of overseas regulatory agencies on trials conducted in Australia
• The roles of Human Research Ethics committees and Research Governance Offices in reviewing clinical trials in Australia
• The Australian research ethical values and the ethical conduct of clinical trials 
• The Australian national legislation impacting the conduct of a clinical trial in Austral
• The different application forms used in submitting a clinical trial to ethics and governance
• The research application and sites coordination process in Australia

The course is also included in Trials Essentials for Investigators in a series of 5 courses with a package certificate