Course curriculum

    1. Objective

    1. Definition of Adverse Events

    2. Adverse Event Classification

    3. Defining Serious Adverse Events

    4. Importance of Reporting AE/SAE

    5. Test Your Knowledge

    1. ICH GCP and FDA Reporting Requirements

    2. Ethical Considerations and Participant Safety

    3. Timelines and Procedures for Reporting Adverse Events

    1. Proper Documentation of Adverse Events and Serious Adverse Events

    2. Tips for Assessing AEs/SAEs

    3. Test Your Knowledge

    1. Investigator Determination of Causality

    2. Investigator Assessment of Clinical Significance in Lab and ECG Findings

    1. Continued Monitoring of AEs/SAEs

    2. Post Learning Assessment Quiz

    3. Conclusion

About this course

  • $40.00
  • 17 lessons
  • 90 minutes

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