Inspection Readiness Is a State, Not an Event

Part of Clinical Project Management (PM) Training: Inspection Readiness and Close-Out.

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

You cannot prepare for an inspection in three weeks

An inspection asks whether the trial was conducted according to the protocol, GCP and the applicable regulations, and it answers that question from the records made at the time. Records created in a hurry afterwards are visibly records created in a hurry afterwards.

The only real preparation is having kept the file properly throughout.

What an inspector looks for in a project manager's world

Whether oversight happened and can be shown. Whether transferred responsibilities were documented and monitored. Whether issues found were followed to closure. Whether the protocol in force at each site matched the approvals. Whether deviations were recorded and reported. Whether vendors were qualified before use.

Notice that every one of those is a documentation question about an activity, not a question about whether you were diligent.

The TMF is the evidence

A trial master file that is complete and contemporaneous is the single strongest thing you can have. Filing everything at the end produces gaps that cannot be closed, because a document that should have existed in March cannot be created in November.

Periodic TMF review during the trial finds the gaps while they are still fixable.

The honest answer

When an inspector asks something you do not know, say you do not know and that you will find out. Guessing produces an answer that the file then contradicts, and a contradiction is far more damaging than an unknown.

The finding you can survive is a gap. The one that does real harm is an inconsistency between what was said and what the record shows.