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: Thursday, April 13, 2022

Time:               12:00 - 1:30 PM (1.5 hr) 

Location:         Virtual Meeting. This class will be held LIVE on the date above. Once enrolled, accept the course invitation. From your dashboard, open the course website. 

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Clinical Research Professional Competency Domain: Clinical Trials Operations (GCPs)
Clinical Research Operations Program: Elective

This is an elective seminar in the Clinical Research Operations Program. Please complete the evaluation at the end of the seminar.

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Optional: Board of Registered Nursing (BRN) Continuing Education Unit (1.5 CEU) 

Spectrum is an approved provider by the California Board of Registered Nursing, Provider Number CEP15435 for 1.5 contact hour(s). If you would like to receive credit for attending this class with BRN credit,  please register on STARS (http://bit.ly/CTR-5083 (Links to an external site.). A $35 administrative fee will be charged to your STAP. You will be required to attend the LIVE session and complete the evaluation before receiving your certificate. 

BRN CANCELLATION POLICY: If you need to cancel, please do so within 24 hours of the course date or notify researchoffice_training@lists.stanford.edu to receive a refund.