Clear Reporting Responsibilities for U.S. Trials
Understand PI and site reporting obligations under U.S. regulations, including when adverse events must be reported to sponsors, IRBs, or other oversight bodies—and when documentation alone is appropriate.
Timelines, Triggers, and Decision Points
Learn how reporting timelines are triggered, how seriousness and relatedness affect reporting expectations, and how to navigate gray areas without over- or under-reporting.
Built for Real-World Site Reporting
Focused on how reporting actually happens at research sites, with practical guidance to support consistent documentation, clear communication, and defensible reporting decisions.
From Definitions to Defensible Reporting
Adverse event reporting is where definitions turn into regulatory action—and where site teams often feel the most pressure to “get it right.” In this session, we focus on PI and site reporting responsibilities for adverse events under U.S. clinical trial regulations, with a practical emphasis on how safety information flows from the site to sponsors, IRBs, and regulatory oversight bodies. You’ll learn how reporting expectations differ by event type, how timelines are triggered, and how reporting decisions are documented and justified in real-world practice. We walk through how sites assess what needs to be reported, who needs to be notified, and when—including sponsor notification, IRB reporting, and follow-up obligations. The session also clarifies common areas of confusion, such as reporting events that are serious but expected, possibly related events, and situations where documentation matters even when formal reporting is not required. Designed for real-world site operations, this session translates regulatory expectations into clear reporting workflows—helping PIs and site teams communicate safety information effectively, stay inspection-ready, and demonstrate ongoing oversight throughout the safety reporting lifecycle. If you support adverse event reporting at the site level and want confidence in your reporting decisions—not guesswork—this session is for you.
Want to keep building your safety reporting foundation?
This session is part of the Safety Reporting for Sites: A Foundations Series bundle, which brings four safety reporting sessions together into one cohesive learning path—available in the ClinIQ Academy catalog.
Curriculum
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1
Safety Reporting- Understanding Site Reporting Requirements- Drugs and Devices
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(Included in full purchase)
Safety Reporting- Site Reporting Requirements- Drugs and Devices
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(Included in full purchase)
Start learning on your path to clinical research confidence.
Accurate reporting protects participants—and protects your site. Build clarity around adverse event reporting expectations and move forward with confidence in every safety decision.
$10.00