A Deviation Is Not a Disaster

Part of Research Assistant (ASSIST) Training: When the Instruction Does Not Fit.

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

What a deviation actually is

A protocol deviation is anything that did not happen the way the protocol says. A visit outside its window. A missed assessment. A sample processed late. A dose taken at the wrong time.

Every trial has them. They are recorded, assessed and counted. Most are minor and change nothing about the result.

The thing that makes them serious

What turns a small deviation into a real problem is hiding it.

An unrecorded deviation means the data looks like something that did not happen. Someone analyzing it later believes the sample was taken in the window when it was not. That is no longer an error in the conduct of one visit; it is an error in the evidence.

Sites are almost never criticized for having deviations. They are criticized for deviations that were not reported.

Report it even when it was your fault

Especially then. Nobody is served by a culture where people hide their own errors, and everyone makes them. The cost of your mistake is small if it is known and large if it is discovered later by a monitor.

If you are worried about how it will be received, say so along with the report. Most coordinators will tell you the same thing: thank you for telling me now.

Write what happened, not what should have

The record should say the sample was taken at 52 minutes, not that it was taken in the window. The description is factual and neutral: what was supposed to happen, what did happen, when, and what was done about it.

Resist the urge to explain it away in the record. The assessment of how serious it is belongs to someone else, and they need the plain facts to make it.