Drug Safety: Adverse Event Reporting

Duration: 3 Hours

Certificate of Completion:

Provided immediately upon successful completion.

Drug Safety: Adverse Event Reporting 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.

Accreditation: GeneEd designates this educational activity for a maximum of 3 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity. This credit may also be applied to the CMA Certification in Continuing Medical Education.

GeneEd, Inc. is accredited by the Institute for Medical Quality/California Medical Association (IMQ/CMA) to provide continuing medical education for physicians. GeneEd, Inc. takes responsibility for the content, quality and scientific integrity of this CME activity.

In addition to physicians, GeneEd Online Training Courses are also applicable for nurses (RNs), doctors (MD and PhDs), clinical research associates (CRAs or monitors), clinical research coordinators (CRCs), investigators, researchers, bioprocess / biomanufacturing workers, QA/QC managers, other healthcare professionals and for patient education.

Drug Safety: Adverse Event Reporting

OUTLINEINTRODUCTION

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: Students completing this course, Drug Safety: Adverse Event Reporting, 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 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).

About GeneEd's Online Training:

* GeneEd Online Training Courses are high-quality, Flash driven, learning tools including voiceovers and dynamically engaging graphic animations.

* This GeneEd Online Training Course is accessible for 90 days via the Internet, and a Certificate of Completion is accessible once requirements are filled.

* GeneEd Online Training Courses have an instructional design which encourages knowledge retention and long term recollection.

* GeneEd Online Training Courses are developed for healthcare professionals (nurses and doctors), clinical researchers, and for patient education.

* To access your GeneEd Online Training Course, your username, password and login URL will be provided to you shortly after ordering.

Price: $275.00 / GBP181.50