By Laurie Meehan
“What tipped you off?” “How did you know to look there?”
When our GCP auditors conduct training and deliver guest lectures, they frequently hear those questions from class attendees. Sometimes the tip-off is something very subtle that requires the keen eye of an experienced auditor to notice. And other times, not so much.
The Principal Investigator and Study Coordinator comments below are real; these are conversations our auditors had with site personnel. Really. No kidding. Pinky swear. The audit findings, not surprisingly, are real too. I do confess to having taken some liberties with the Auditor Notes and Remediation Recommendations.
