Clinical Research CoordinatorCourse 5 of 8

Clinical Research Coordinator

Full course · Participant Management: Screening to Retention

Temperature excursions, expiration, and handling deviations — Participant Management: Screening to Retention

Temperature excursions, expiration, and handling deviations

Respond to temperature excursions with proper quarantine procedures, manage expiration proactively with FEFO, and classify and document IP handling deviations.

24 min

When things go wrong with investigational product

The preceding three lessons taught the standard operating rhythm of IP accountability: receive, verify, store, dispense, reconcile. When every step proceeds as designed, the work is precise but predictable. This lesson is about what happens when it does not.

Temperature excursions. Expired product discovered on the shelf. A kit that arrives damaged. A participant who stores insulin on a windowsill in August. These are not hypothetical scenarios — they are events that occur at clinical trial sites with a regularity that surprises new coordinators and no longer surprises experienced ones. The question is not whether an IP handling deviation will occur at your site. The question is whether you will respond correctly when it does.

And "correctly" has a specific meaning in this context. It means: do not use the product until you have authorization. Document everything. Notify the right people. Wait for a determination. The instinct to fix the problem quickly — to put the warm vials back in the refrigerator, to dispense the kit that expired yesterday because the replacement has not arrived yet, to assume that a brief excursion "probably did not matter" — is precisely the instinct that must be overridden by procedure.

I have taught this material long enough to know that the most dangerous moment in IP management is not the excursion itself. It is the five minutes afterward, when the coordinator must decide whether to follow procedure or take a shortcut. This lesson exists to ensure you follow procedure.

What you will learn4 objectives

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

Execute the temperature excursion response sequence: quarantine, document, notify the sponsor, and await determination before using or destroying the product
Manage IP expiration proactively using first-expiring, first-out (FEFO) dispensing and systematic expiration monitoring
Respond to other IP handling deviations including damaged product, wrong kit dispensing, and participant storage errors
Document and classify IP handling deviations with sufficient detail for root cause analysis and regulatory review

Progress saves itself — finish reading and this lesson completes

This is just the beginning

When things go wrong with investigational product