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Regulatory Coordinator4 of 6
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Module 1: Lesson 1
Reportable events definitions: the OHRP framework and how IRBs interpret it
Apply the OHRP three-part definition of unanticipated problem to safety events, analyze how different IRBs operationalize the framework, and evaluate edge cases using a risk-based approach per ICH E6(R3) Principle 7.
"Unanticipated problem" is a term of art
There is a phrase in clinical research that causes more confusion -- and more reporting errors -- than perhaps any other: unanticipated problem involving risks to participants or others. It sounds like plain English. It sounds like it means "something bad that no one expected." And that intuitive reading is precisely what leads regulatory coordinators, investigators, and even some IRB administrators to apply it incorrectly.
The phrase is not plain English. It is a regulatory term of art, defined by the Office for Human Research Protections (OHRP) with a specificity that transforms a vague concept into a testable, three-part determination. Not every bad outcome is an unanticipated problem. Not every serious adverse event is an unanticipated problem. Not every unexpected event is an unanticipated problem. An event must satisfy all three prongs of the OHRP definition simultaneously before it qualifies -- and understanding this distinction is, in my view, the single most important analytical skill the regulatory coordinator brings to IRB safety reporting.
In Lesson 1, you built the classification framework: four categories of information the IRB requires. You learned that unanticipated problems are Category 1. But knowing the category exists is not the same as knowing how to determine whether a specific event belongs in it. That determination is what this lesson teaches.
And here is the complication I need to prepare you for up front: the OHRP framework is clear. IRBs' interpretation of that framework is not uniform. Some IRBs apply the three-part test precisely as OHRP defined it. Others layer their own requirements on top, requiring reports of events that would not meet the OHRP definition at all. The RC managing a multi-IRB portfolio must navigate this interpretive diversity -- and that navigation requires understanding both the canonical definition and its real-world variations.
What you will learn
By the end of this lesson, you will be able to:
Regulatory Coordinator
Full course · Safety Reporting Coordination