What an Inspector Asks an Investigator

Part of Sub-Investigator (SUBI) Training: Inspection Readiness and Your Own Record.

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

They will want to speak to you

Coordinators answer most operational questions. Inspectors ask investigators about medical judgment, oversight and whether you knew what was happening in your own study.

The questions that come up

Were you delegated and trained, and were the dates before the work? Did you review laboratory results, and is that documented? How did you reach this attribution? What did you do about this deviation? How do you know what happens at this site when you are not here?

Oversight is a question about you

A sub-investigator who performed tasks without knowing the protocol's structure, or who signed assessments they did not make, is the specific finding inspectors look for.

Being able to describe how the study runs is part of being delegated to it.

Answer what is asked

Say what you know. Say you do not know when you do not, and offer to find out.

Speculating creates statements that have to be defended later, and they are rarely accurate under pressure.

Do not improve the record beforehand

Completing notes, signing old laboratory reports or tidying files before an inspection turns a minor gap into a serious finding about integrity.

An unsigned report is a gap. A report signed two years late, dated as though it were not, is something else.

Your own file is inspected

CV, registration, GCP training, protocol training, delegation entry and dates. All current, all dated, all consistent.

This is the easiest part to keep right and one of the most commonly wrong.

Findings are normal

Inspectors expect problems. What they assess is whether the site found them, reported them and corrected the cause.

A site with no findings and no reported deviations is not believed, and rightly.