Topics covered in this subject include: • Overview of Drug Development • Conducting Clinical Research (CCR) - Essential GCP Training for New Coordinators • 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 research coordinator in clinical research
Understand the purpose and role of regulatory documents for initiating and running a clinical trial
Understand the purpose and operational responsibilities of a research coordinator in maintaining the quality standards defined by Australian legislation and Good Clinical Practice