Course Contents
1. The Basics of Clinical Research and what are the basics responsibilities of the personnel who operate in Clinical Research Department
2. The Clinical Trials and its Phase
3. Adverse Drug Event
4. Adverse Drug Reaction
5. The Indian Clinical Research Industry
6. The knowledge of ICH GCP Guidelines that are in place for Clinical Research and Clinical Trials
7. The Ethics Committee
8. Informed Consent Form
9. Safety Reporting etc.
10. Documentation
11. Protocol Writing and Medical Writing
12. Clinical Trials rules and regulations to be followed and its Management System