Topics covered in this subject include: • Overview of Drug Development • Essential Good Clinical Practice Training for New Clinical Research Associates • Managing Regulatory Documents
Intended learning outcomes
Students who successfully complete this subject should:
Understand the drug development pathway and its link to clinical research
Understand the role of the Clinical Research Associate in clinical research
Understand the purpose and role of regulatory documents necessary for initiating and running a clinical trial
Understand the purpose and operational responsibilities of a Clinical Research Associate in maintaining the quality standards defined by Australian legislation and Good Clinical Practice