Mastering the Event Reporting Cycle: Understanding Adverse Events (AEs)
Please note this course was formerly “Mastering the Event Reporting Cycle: Understanding Your Impact on Patient Safety”.
Efficiently identify and report safety events in your clinical trials.
Subject safety is top priority in clinical research. As such, safety reporting is the duty of all clinical research professionals, both at the site and sponsor/CRO levels.
Appropriate for all clinical research professionals, this course guides you through the complete event reporting cycle and critical timelines, as defined in ICH E2a and E6 Guidelines.
Make sure you understand why events are reported and their impact on overall subject and patient safety.
This course is ideal for any of the following situations:
Introduction to or refresher on roles, responsibilities, definitions and timelines as they relate to safety reporting
A component of a corrective and preventive action plan following an audit or inspection
Preparation for an ACRP Certification exam
Upon completion of this training program, participants should be able to:
Define and describe clinical safety terminology.
Report safety concerns to stakeholders via the correct form and per ICH E2a Section III Standards for Expedited Reporting, and include the appropriate Key Data Elements according to Appendix I.
Apply the guidelines for specific cases, as defined under Miscellaneous issues (Section III E).
Explain when a sponsor should amend the Investigator Brochure.
This course helps clinical researchers of all types build competency in Data Management and Informatics, Medicines Development and Regulation, and Scientific Concepts and Research Design. Explore Competencies >