Drug Safety: Adverse Event Reporting

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Program/Course ID: ADVEV Enrollment Period: 12 months. Average Learning Time: ~. Additional Resources: Supplemental materials & activities. Credit Hours: 3 credits. Method of Training: Online, asynchronous, self-paced eLearning. LMS Compatible: SCORM-compliant; request a quote. Accessibility: 24/7 access to all program materials. Demonstration: Four (4) free trial courses are available. Group/Employee Training: Click here to request a quote or invoice. Final Assessment: Multiple choice; unlimited attempts. Certificate: Encrypted PDF with QR validation code.

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Tuesday, June 02, 2026 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.

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Outline: INTRODUCTION 1. Course Information 2. Interface Tour 3. Course Objectives KEY PLAYERS 4. Objectives 5. Key Players and Components 6. Progress Check WHY WE COLLECT ADVERSE EVENTS 7. Objectives 8. History of AE Reporting 9. Progress Check DEFINITIONS 10. Objectives 11. Adverse Events 12. Serious Adverse Events 13. Causality 14. Adverse Drug Reactions 15. Expectedness 16. SUA/SUSAR 17. Progress Check REPORT COLLECTION 18. Objectives 19. Collection in Clinical Studies 20. Follow-up Activities 21. Monitoring and SAEs 22. Phase IV Reports 23. Pregnancy 24. Other Special Cases 25. Timelines 26. Progress Check TERMINOLOGIES 27. Objectives 28. Old Terminologies 29. MedDRA 30. CTCAE V3 31. Progress Check CONCLUSION 32. Summary		Objectives: Describe the role of the Sponsor Organization. Describe the role of the Responsible Contact Person. Explain an Interventional Clinical Trial. Describe the elements of a valid SAE report. Indicate why Adverse Events are collected. Define and differentiate between: -Adverse Events -Serious Adverse Events -Adverse Drug Reaction -Serious Unexpected Associated Adverse Event -Suspected Unexpected Serious Adverse Reactions Outline the correct timeline for reporting Serious Adverse. Events and Serious Adverse Event follow-up information in clinical trials. Explain the correct sequence of information flow in the Serious Adverse Event reporting process. Identify who is responsible for what and when in the Serious Adverse Event collection and reporting process. Describe the roles and responsibilities in the Adverse Event handling process. Describe the Adverse Events/Serious Adverse Event handling activities at the study site. Discuss different terminologies used to report adverse events in clinical trails. Describe the Medical Dictionary for Regulatory Activities (MedDRA) and how the hierarchy of terms is applicable through all phases of the development cycle. Discuss the Common Terminology Criteria for Adverse Events (CTCAE v.3) as outlined by the National Cancer Institute (NCI).

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Comments: For quotes or invoices please provide the titles of the course(s) and number of students.	Drug Safety: Adverse Event Reporting