Regulatory Compliance & Ethics in Clinical Trials

Explore the ethical protections and regulatory submission pathways that support safe, responsible clinical trials. The course covers informed consent under 21 CFR Part 50, IRB/Ethics Committee oversight (21 CFR Part 56), Investigational New Drug (IND) applications (21 CFR Part 312), and practical strategies for maintaining regulatory compliance.

Course Benefits & Career Prospects

• Understand ethical principles and subject protection obligations in clinical studies.
• Navigate U.S. FDA regulatory pathways and core submission elements (IND).
• Distinguish IRB/Ethics Committee review requirements and communication workflows.
• Support consent process oversight and documentation compliance at research sites.
• Job placement assistance: preparation for ethics/regulatory coordinator or study compliance roles.

Modules

• Regulatory Submission & Approvals
• Protection of Human Subjects (Informed Consent) – 21 CFR Part 50
• Institutional Review Board (IRB) & Ethics Committee – 21 CFR Part 56
• Investigational New Drug Application – 21 CFR Part 312