The Association of Clinical Research Professionals

​​Mastering the Event Reporting Cycle: Adverse Events with ICH E6(R3) Guidance​

​​Participant safety is the foundation of every clinical trial, and effective safety event reporting is essential to protecting participants and maintaining data integrity.

This course provides a clear, practical walkthrough of the full adverse event (AE) reporting cycle—what must be reported, why it matters, and how responsibilities are shared across site, sponsor, and service provider teams. Updated with the latest principles from ICH E6(R3) and aligned with ICH E2A, this course demystifies evolving expectations for roles, responsibilities, documentation, and communication.  Designed for all clinical research professionals, this course is ideal for those who need: An introduction or refresher on definitions, timelines, and core responsibilities under E6(R3)Support with CAPA development following an audit or inspection Foundational knowledge for ACRP Certification exam preparation By the end, you’ll be better prepared to meet global regulatory expectations, strengthen your safety oversight practices, and stay inspection‑ready under the latest Good Clinical Practice standards.​ 

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

  • ​​Define and describe essential clinical safety terminology in accordance with ICH E6(R3) and ICH E2A 
  • ​Accurately record and communicate safety concerns to stakeholders using correct forms and processes, including the Key Data Elements required for expedited reporting under ICH E2A Section III. 
  • ​Apply updated guidance to special cases and complex reporting scenarios by using principles from ICH E2A Section III.E and ICH E6(R3) to support proportionate, risk‑based decision‑making. ​ 

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