Full course description
**This is a NEW core class in the Clinical Research Operations Program (CROP). If you are starting the CROP program in January 2025 or later, you will need to complete this class. For those who started the program prior to 2025, this is not a required core class. Thank you**
Learn about prompt and proper management of adverse events (AEs) and serious AEs (SAEs) encountered in human subject research with drugs, how they must be documented and tracked, and, under certain conditions reported to Sponsors, regulatory agencies, and IRBs. Put this learning to practice with case studies.
Learning Objectives
At the conclusion of this class, you will be able to:
- Identify adverse events and adverse events classification
- Explain the Stakeholder responsibilities
- Recognize the Information flow
- Understand the Reporting timelines
- Discuss Case studies
Audience: Research coordinators, nurses, faculty, staff, and post-doctoral scholars working on clinical research projects at Stanford University.
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Session Date: Wednesday Feb. 26th, 2025
Time: 12:00 - 2:00 PM
Location: Virtual Meeting. This class will be held LIVE on the date above.
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Clinical Research Professional Competency Domain: Clinical Trials Operations (GCPs)
Clinical Research Operations Program: Core class
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