What will I learn?
- Definition and role of Ethics in Clinical trials
- Review of the development of research Ethics through various triggers for tougher regulations
- Ethical principles of the ICH
- Review of International Legislation
- Types and function of Independent Ethics Committees – constitution, membership, procedures and documentation required
- Responsibilities of Investigators towards Ethics Committees
- Distinction between Independent Data Monitoring Committees and Ethics Committees
- Informed Consent Form – definition, elements, exceptions to the informed consent principles, revisions, protection of vulnerable subjects
- Research fraud and misconduct – definition, prevention, fabrication and falsification
- Inspections vs Audits – definition, requirements, processes