​​Informed Consent Scenarios with ICH E6(R3) Guidance​

This interactive, scenario-driven training course equips clinical research professionals with the skills to ensure informed consent is obtained from the right subject, using the correct forms, by authorized personnel, through a compliant process, at the appropriate time—with complete and accurate documentation.

Through immersive role-play in realistic scenarios, participants step into the roles of patient, study coordinator, investigator, sub-investigator, and study monitor/CRA. This 360-degree experience deepens understanding of informed consent principles and highlights the perspectives and responsibilities of each stakeholder.

Designed to move learners beyond theoretical knowledge, the program uses adaptive learning to build and reinforce the competencies essential for proper informed consent. Participants actively engage with complex, real-world situations, strengthening their ability to apply regulatory requirements and ethical standards in practice.

Updated to reflect the latest guidance in ICH E6(R3), this training is relevant for site teams and monitors/CRAs working on behalf of sponsors and CROs. It covers key regulatory frameworks including the Declaration of Helsinki, U.S. FDA guidelines, WHO recommendations, and other globally recognized standards.

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

• ​​Describe what informed consent is and its role in clinical research 

• ​Apply the principles of informed consent, including participant autonomy, regulatory compliance, ethical communication, and proper documentation throughout the consent process 

• ​Define common informed consent issues and explain the concept of root cause analysis 

• ​List factors that may affect a participant’s ability to understand the consent form 

• ​Demonstrate the two key types of documentation required for informed consent 

• ​Identify best practices for obtaining informed consent in a compliant and participant-centered manner​ 

This course is ideal for anyone involved in conducting, documenting, or verifying informed consent in clinical research—especially Principal Investigators, Sub-Investigators, CRCs, CRAs, and Clinical Trial Assistants.

Approved for 2.0 ACRP Contact Hours | Available 1 Year from Enrollment Date