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Thursday, March 21, 2019
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Drug Safety: Adverse Event Reporting (ADVEV)

Certification Training
Duration: 2.8 hours, Online (the average time to complete the training program, including final assessments).
Credits Hours: 3
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

Contact the BioPharma Institute for more information.

BioPharma Institute LogoTraining Program: Drug Safety: Adverse Event Reporting
Training Provided By: BioPharma Institute

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment. BioPharma Institute ReviewsThis 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.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

The Drug Safety: Adverse Event Reporting course is found in the following professional certification program(s):


1. Course Information
2. Interface Tour
3. Course Objectives

4. Objectives
5. Key Players and Components
6. Progress Check

7. Objectives
8. History of AE Reporting
9. Progress Check

10. Objectives
11. Adverse Events
12. Serious Adverse Events
13. Causality
14. Adverse Drug Reactions
15. Expectedness
17. Progress Check

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

27. Objectives
28. Old Terminologies
29. MedDRA
30. CTCAE V3
31. Progress Check

32. Summary


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).

Online Training Program Benefits:

  • Immediate access to training: Instructions, username, password and receipt of payment emailed instantly upon online enrollment
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
  • Self-paced courses: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
  • Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
  • Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization

For more information on the BioPharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email

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