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
Adverse Event/ Serious Adverse Event Management Basics for Drug Trials
Welcome to our introductory session on adverse events in clinical research, designed specifically for research coordinators who are new to the field and/or our institution. This presentation will equip you with essential knowledge and skills to effectively track and manage adverse events, ensuring participant safety and maintaining study integrity.
Learning Objectives
At the conclusion of this class, you will be able to:
- Importance of Tracking Adverse Events: Discover why meticulous tracking is vital for safeguarding participants, complying with regulations, and ensuring the success of clinical trials.
- Definitions and Types of Adverse Events: Gain clarity on key terms such as Adverse Events (AEs), Serious Adverse Events (SAEs), and Serious Unexpected Suspected Adverse Reactions (SUSARs).
- Process of Capturing Events: Learn the steps involved in observing, documenting, and reporting adverse events.
- Escalation and Reporting: Understand basic principles and timelines for escalating adverse events.
- Real-Life Examples and Stories: Engage with real-world scenarios and stories that highlight the impact of effective adverse event management.
Audience: Research coordinators, nurses, faculty, staff, and post-doctoral scholars working on clinical research projects at Stanford University.
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Session Date: Thursday Nov. 6, 2025
Time: 9:00 - 11:00 AM
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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