​​Clinical Trials 101: An Introduction with ICH E6(R3) Guidance

Learn the essentials of clinical trials and the global standards that govern them. This 120-minute online course provides a clear, structured introduction to the process, roles, and guidelines that ensure ethical and effective research.

You’ll gain a solid understanding of what clinical trials are, how they safeguard participant safety and uphold ethical standards, and the international guidelines that shape research, including ICH GCP E6(R3). The course also explores the roles and responsibilities of key stakeholders, the journey of medical products from discovery to approval, and the principles of Good Clinical Practice that ensure scientific integrity and participant protection.

Whether you’re new to clinical research, considering a career in the field, or supporting trials indirectly, this program will help you build foundational knowledge about clinical research.

At the end of this course, participants should be able to:

• Define what a clinical trial is and identify the key components of a clinical study, including site activities and their requirements.
• Explain the core ethical principles that guide clinical research.
• Describe how informed consent protects the safety, rights, and welfare of research participants in clinical trials.
• Outline the development process for medicinal products and the regulations that govern it.
• Recognize good clinical practices for ensuring the safety of the research participant and the scientific validity in clinical trials
• Identify the key roles and responsibilities in clinical trials and explain how each contributes to participant safety, data integrity, and compliance with Good Clinical Practice.

Course Not Approved for ACRP Contact Hours | Available 1 Year from Enrollment Date