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Adverse Events

Description: This is an introductory course on Adverse Events. It introduces the reasons for collecting Adverse Events and Serious Adverse Events in clinical studies, the importance of reporting Adverse Events and Serious Adverse Events, and the steps that should be taken when reporting an Adverse Event.

COURSE 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

COURSE OBJECTIVES

Students completing this course should be able to:

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 Reactions
- Serious Unexpected Associated Adverse Events
- 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 trials
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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