Regulatory Coordinator

Full course · Safety Reporting Coordination

Triage and review: determining which communications require investigator action, IRB submission, or consent revision — Safety Reporting Coordination

Triage and review: determining which communications require investigator action, IRB submission, or consent revision

Apply a four-gate triage methodology to every inbound sponsor safety communication, producing documented decisions at each gate that create a defensible audit trail and drive the correct downstream actions.

26 min

Gut feeling is not a triage methodology

In Lesson 1, you learned to classify sponsor safety communications into four types. Classification tells you what a communication is. But it does not tell you what to do with it -- not specifically, not for a particular study, not for a particular investigator, not for the IRB that oversees that study at your site.

I have watched regulatory coordinators at busy sites receive an IND Safety Report, scan the first page, decide it "looks important," and immediately route it to the principal investigator with a sticky note saying "FYI -- please review." That is not triage. That is forwarding. And forwarding everything with equal urgency accomplishes two things, both destructive: it overwhelms the investigator with undifferentiated noise, and it creates the illusion that the RC has processed the communication when, in fact, no processing has occurred.

Real triage is a structured decision process. It produces a documented, defensible record of what the RC determined about each communication and why. It routes some communications for immediate investigator review and flags others as routine acknowledgments. It identifies which communications trigger IRB reporting obligations and which do not. And it catches the small but critical subset of communications that require consent revisions -- the ones that, if missed, mean your participants are enrolled under a consent document that no longer accurately describes the study's risks.

This lesson builds the triage methodology. Four gates. Explicit criteria at each one. A documented decision at every step. By the end, you will have a repeatable process that works whether you are processing three communications on a quiet Tuesday morning or 17 during a safety signal cascade on a Friday afternoon.

What you will learn3 objectives

By the end of this lesson, you will be able to:

Apply a four-gate triage methodology to inbound sponsor safety communications: Gate 1 (new safety information), Gate 2 (investigator review required), Gate 3 (IRB reporting obligation), Gate 4 (consent revision needed)
Analyze how the same communication may produce different triage outcomes depending on study protocol, enrollment status, and IRB reporting policies
Design a triage documentation template that records the communication, the decision at each gate, the rationale, and downstream actions initiated

Progress saves itself — finish reading and this lesson completes

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Gut feeling is not a triage methodology