Unanticipated Problems—Clearly Defined
Understand how unanticipated problems are defined under U.S. regulations and OHRP guidance, including the three criteria that must be met for IRB reporting.
Beyond Adverse Events
Learn why unanticipated problems extend beyond medical events to include protocol deviations, data issues, confidentiality breaches, and newly identified risks.
Recognizing UPs in Real-World Practice
Identify the practical signals that often indicate an unanticipated problem—such as protocol changes, consent updates, enrollment pauses, or added monitoring—and what those actions mean for reporting.
When Safety Information Becomes an Unanticipated Problem
Unanticipated Problems are one of the most misunderstood—and inconsistently reported—areas of clinical research safety oversight. In this session, we focus on how unanticipated problems are defined and applied under U.S. clinical trial regulations, using OHRP guidance and federal expectations to clarify when new information rises beyond a routine adverse event. You’ll learn how unanticipated problems are identified, why they extend beyond medical events, and how they connect safety, ethics, data privacy, and participant protection. We walk through the three required criteria for an unanticipated problem and show how sites often recognize them in practice—through protocol changes, consent updates, enrollment pauses, added monitoring, or participant notifications. The session also clarifies the overlap between adverse events and unanticipated problems, helping you understand what must be reported to the IRB and why. Designed for real-world site operations, this session helps investigators and site teams move beyond uncertainty and apply a consistent, defensible framework for identifying, documenting, and reporting unanticipated problems—so participant protections remain central throughout the life of the study. If you’ve ever wondered whether something is “more than just an AE,” this session gives you the clarity to answer that question with confidence.
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
Unanticipated Problems
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(Included in full purchase)
Unanticipated Problems
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(Included in full purchase)
Start learning on your path to clinical research confidence.
Unanticipated Problems don’t come with labels—but they do leave clues. Build the confidence to recognize when new information changes participant risk, triggers IRB reporting, and requires action to protect subjects and the integrity of the study.
$5.00