Recognizing an Adverse Event You Cannot See

Part of Decentralized Trials (DCT) Training: Safety at a Distance.

About 2 minutes. Free, in your language, no account needed.

The obligation is identical, the information is worse

Adverse events must be identified, assessed and reported to the same standard as at a site. What is missing is everything you would normally observe.

So you compensate with questions and with attention to what does not fit.

Ask openly before asking specifically

"How have you been since we last spoke?" first. Symptom checklists afterward.

A checklist asked first anchors the participant to the listed items, and the thing that matters is often not on the list.

Listen for what is mentioned in passing

The most important sentence in a remote visit is usually an aside. "I've been a bit dizzy standing up, but that's probably the weather."

That is a report. Follow it.

Cross-read your data sources

A participant reporting no problems while their device shows a resting heart rate climbing over a week is telling you two different things.

At a site, a clinician might have noticed. Remotely, the data is the observation, and somebody has to look at it against what was said.

Capture severity, seriousness and onset properly

Severity is how bad. Seriousness is a regulatory definition with specific criteria. They are independent, and a mild event can be serious.

Onset is when it started, not when you heard about it. Ask directly, because remote reporting is often delayed and the gap matters.

Report on the clock that applies

A serious adverse event has a reporting timeline that starts at awareness. Awareness means when the site became aware, including during a phone call on a Friday afternoon.

Being remote does not extend the clock.

Do not assess causality alone

Attribution is the investigator's judgment. Your job is a complete, accurate account of what happened, when, and what else was going on.