The Investigator Interview

Part of Principal Investigator (PI) Training: Inspection, Findings and the Record.

About 4 minutes. Free, in your language, no account needed.

Why this matters

Almost everything an inspector examines at your site can be prepared by your team. One thing cannot: the conversation with you. It is usually short, it is not adversarial, and it is the part that determines whether an inspector concludes the site has real investigator oversight or paperwork that describes it.

You cannot revise for it in the week before. You can be the kind of investigator for whom it is easy.

Three different visitors

The Glossary distinguishes them and the distinction changes what is happening in your building.

• Monitoring is the sponsor's oversight activity, ongoing throughout the trial, done by their monitor.
• An audit is a systematic, independent examination of trial activities and documents — usually by the sponsor's quality function, independent of the trial team.
• An inspection is conducted by a regulatory authority. It is an official review of documents, facilities, records and any other resources the authority considers related to the trial.

All three depend on the same obligation. Section 2.12.14, with §3.16.4, requires direct access to all trial-related documents for the monitor, auditor, IRB/IEC and regulatory authority. Participants agreed to this in consent. Access is not something you grant as a favor and it is not something you may narrow.

What the interview is actually testing

Inspectors are not checking whether you memorized the protocol. They are checking whether the person whose name is on the trial knows what happened at their site. In substance, four questions:

1. Do you know your own trial? The objective, the population, the primary endpoint, roughly how many participants you enrolled, the significant events among them.
2. Can you describe your oversight, concretely? Not "I supervise the team" but what you do, how often, and where the evidence is. This is Module 2, and it is why those four routines leave dated records.
3. Do you know what went wrong? Your deviations, your serious events, your findings from the last audit, and what changed afterwards. An investigator who knows their own problems reads as in control. One who is surprised by them reads as absent.
4. Are the answers consistent with the documents and with your staff? Inspectors triangulate. The damaging outcome is not an imperfect site; it is a site whose investigator describes something the records do not show.

How to answer

Answer the question asked. Short, factual, then stop. Volunteering tangents opens areas nobody was examining.

Say when you do not know, then find out. "I don't recall — let me get the record" is a completely acceptable answer and a far better one than a guess. A guess that turns out to be wrong is worse than silence, because it makes everything else you said uncertain.

Never speculate. "It may have been because..." becomes a finding about a cause you invented.

Do not blame your staff. Under §2.3 the supervision was yours. Blaming a coordinator confirms the supervision finding rather than deflecting it.

Never alter a record during an inspection. Not to correct an obvious error, not to add a signature that should have been there. Note the discrepancy, address it afterwards through the proper correction route.

Preparing without pretending

An inspection announcement usually gives you some notice. Use it for reality, not theatre.

• Read your own deviation log, serious event list, and the last monitoring visit follow-up letter.
• Walk the participant journey for two or three participants end to end: consent, eligibility, visits, events, data. This is what an inspector will do.
• Confirm the delegation log reconciles with the source records and the training files.
• Brief your team on the same three rules — answer what is asked, say when you do not know, change nothing.
• Be present, or make sure a designated sub-investigator is. An investigator unavailable during their own inspection is itself a signal.

Key takeaways

• §2.12.14 and §3.16.4 require direct access; participants agreed to it in consent and it is not discretionary.
• Monitoring, audit and inspection are three distinct activities with three distinct actors.
• The interview tests whether you know your trial, can describe your oversight concretely, and know what went wrong.
• Answer the question, admit what you do not know, never speculate, never blame staff, never alter a record.