You Do Not Decide If It Matters

Part of Research Assistant (ASSIST) Training: Noticing What Has to Be Told to Someone.

About 1 minutes. Free, in your language, no account needed.

Your job is to notice and to tell

There is a whole discipline in deciding whether an event is related to a treatment, how serious it is, and what has to be reported to whom by when. None of that is yours.

What is yours is noticing that something happened and making sure someone qualified hears about it promptly.

The most damaging thing a new person can do is decide privately that something is probably nothing.

What counts as something

Anything the participant reports that was not there before. Anything you observe that seems off — they look unwell, they are unsteady, they mention pain. Any hospital visit, any new medicine, any fall, any change to how they are taking the treatment.

It does not matter whether it sounds connected to the study. Connection is somebody else's assessment.

There are clocks

Certain serious events have to be reported within a fixed number of hours of the site becoming aware of them. Site awareness can begin with you.

That is why "I was going to mention it tomorrow" is a problem. The clock may already have started and nobody senior knows.

Say it plainly

You do not need medical language. "Mrs Patel said she has had chest pain twice since Tuesday" is exactly right. Attempting a clinical description risks adding meaning you did not intend.

Report the words you heard and what you saw, and let the clinician do the interpreting.