When things go wrong: managing the unexpected

The centrifuge breaks at 10:17 AM

The participant is mid-visit. The blood draw just happened -- three lavender-tops and a gold for the protocol-specified pharmacokinetic samples, each with a stability window measured in minutes, not hours. The coordinator reaches for the centrifuge, presses the start button, and nothing happens. No hum. No spin. Nothing. The display is dark.

The coordinator's phone rings. It is the sub-investigator calling from the third floor -- a different participant, enrolled in a different study, has developed hives and lip swelling 40 minutes after receiving the study drug. The sub-investigator needs the coordinator now. The principal investigator is in the operating room for the next three hours and cannot be reached.

And then the EDC system locks out. A banner across the top of the screen reads: "Scheduled maintenance -- system unavailable until 2:00 PM." The coordinator had not seen the notification buried in last Friday's email.

This is not a hypothetical. Every coordinator I have spoken with can tell you a story like this -- the morning when multiple things broke at once and no playbook existed for the combination. The individual disruptions were manageable. The convergence was not.

The previous lessons in this module gave you frameworks for the planned work: how to structure a day, how to prioritize across studies, how to manage the administrative weight. This lesson addresses what happens when the plan fails. Not if. When. Because the defining characteristic of clinical research operations is not that things go wrong occasionally -- it is that things go wrong regularly, and the coordinator's response in the first 15 minutes determines whether a disruption becomes a footnote or a crisis.

The centrifuge breaks at 10:17 AM

The centrifuge breaks at 10:17 AM

What you will learn

When things go wrong: managing the unexpected

The centrifuge breaks at 10:17 AM

What you will learn