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Drug Safety: Adverse Event Reporting

Drug Safety: Adverse Event Reporting Certification Training


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.
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.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.

2024 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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Benefits of Training with Biopharma Institute

Immediate access to courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.

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Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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For quotes or invoices please provide the course(s) and number of students.