Things That Are Easy to Miss

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

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

The events that do not announce themselves

Something that stopped. A participant who says the headaches went away is describing an event that happened and resolved. It still counts.

Something they blame on themselves. "I have been clumsy lately" or "I have not been sleeping, but that is just me." People explain symptoms away, and the explanation is not an assessment.

Something from another doctor. A new tablet from their own GP, a hospital appointment, a change to an existing medicine. Other medicines matter to a trial and nobody at your site knows about them unless someone asks or the participant mentions it.

Something that happened weeks ago. A late report is still a report. Never suppress it because the moment passed.

Pregnancy

Pregnancy, or a partner's pregnancy, is reportable in almost every trial whether or not anyone considers it an adverse event, because the treatment may affect it. It frequently gets mentioned casually and to the most junior person present.

Pass it on immediately.

Compliance is information too

Missed doses, doubled doses, stopping early, taking it at the wrong time of day. Participants often do not volunteer this because they think they will be told off.

If someone tells you, thank them and pass it on. Treat it as useful rather than as a confession, and you will keep hearing about it.

When nothing happened

If a participant says they have been completely fine, that is worth recording too where your site asks for it. "No events reported" is information. A blank is not.