“Adverse Events/Serious Adverse Events & Unanticipated Problems Identification & Documentation”
Best Practice Hour Seminar Series
June 17, 2025
12:00 PM - 1:00 PM
Location
Virtual via Zoom
Calendar
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https://clic-ctsa.org/publications/ecrptq-competencies
Description:
The Best Practice Hour (BPH) is a series sponsored by the University of Illinois Cancer Center and the UIC Center for Clinical and Translational Science. Each session will explore best practices for one aspect of conducting human subjects research (HSR).
OBJECTIVES:
- Identify how GCPs protect research participants
- Define adverse event (AE)
- Define criteria for a serious adverse event (SAE)
- Specify Research team members’ responsibilities for managing AE/SAE
- Identify criteria for Prompt Reporting to the IRB
- Identify minimum criteria for SAE reporting to the FDA and/or sponsor
Speaker:
Lisa Lindemann, BSN RN
Senior Clinical Research Coordinator
Center for Clinical and Translational Science
Competency Area:
#4: Clinical Trial Operations
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Date posted
Dec 5, 2024
Date updated
Dec 5, 2024