The Association of Clinical Research Professionals

​​Investigator Responsibilities Under ICH E6(R3) Guidance​

​​Clinical investigators play a critical role in protecting trial participants and ensuring the integrity of clinical research.

This 90-minute course explores investigator responsibilities through the lens of ICH E6(R3), with supporting references to applicable FDA regulations and related ICH guidance. Through practical examples and real-world scenarios, you’ll examine expectations for investigator oversight, accountability for delegated activities, and the responsibilities that remain with investigators throughout the trial lifecycle. The course also addresses protecting participant rights, safety, and well-being; maintaining complete and reliable trial records; supporting inspection readiness; and understanding how risk-proportionate, quality-focused thinking informs investigator oversight and decision making. By strengthening your understanding of investigator responsibilities under ICH E6(R3), you’ll be better equipped to lead compliant, participant-centered clinical research and support the successful conduct of clinical trials.​ 

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

  • ​​Explain the core responsibilities of a clinical investigator under ICH GCP E6(R3) and applicable regulatory requirements 
  • ​Describe expectations for investigator supervision and oversight of a clinical trial, including delegated activities 
  • Identify key responsibilities related to protecting the rights, safety, and well-being of trial participants 
  • Describe how risk-proportionate, quality-focused thinking informs investigator oversight during clinical trial conduct​ 

Approved for 1.5 ACRP Contact Hours | Available 1 Year from Enrollment Date