CRA1: Essential Good Clinical Practice Training for New Clinical Resarch Associates (14 hours)
- Therapeutic goods and their regulation and access to unapproved therapeutic goods
- Critical concepts in clinical development, including protocol development
- The role of the CRA in research
- Good Clinical Practice
- Getting a study started and putting together an ethics submission
- Clinical trial approvals
- Adverse event management
- Clinical trial monitoring - the whole story
- Audit and common quality findings