The Protocol Does Not Cover Everything

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

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

Real visits are untidy

Protocols are written before anyone meets the participants. They cannot anticipate that someone arrives with a relative who wants to sit in, that the equipment reads differently today, that a participant is fasting when they were not supposed to be, or that a dose was taken two hours late.

Gaps are normal. They are not a sign the protocol is bad or that you have missed something obvious.

What to do with a gap

Stop before you improvise. The instinct to fill the gap sensibly is the risky one, because your sensible answer and the next person's may differ, and then two participants were handled two different ways.

Ask someone who can decide. Usually the coordinator; for anything clinical, the investigator. There is almost always someone reachable.

Write down what was decided and by whom. "Coordinator advised proceeding with the visit and recording the delay" is a record. "We managed it" is not.

Do not guess at a medical question

Whether a participant can still take part after missing two doses, whether a symptom matters, whether a value is out of range enough to act on — none of those are yours. You are not being cautious by handing them over. You are routing them to the person qualified to answer.

Gaps that keep happening

If the same gap appears at every visit, the protocol or the local process probably needs adjusting, and someone should know. Saying "this comes up every time and we handle it differently depending who is on" is genuinely useful information.

The person who notices a recurring gap is often the person doing the task most often. That may well be you.