Study Sites: Too Many Vendors, Too Little Time

By Laurie Meehan

“I can’t get the IWRS to assign a kit number.”

“My ECG reports take forever to come back from the Core Lab.”

“The eCRF won’t let me create a new subject.”

“This stupid machine is blinking an error code again.”

Sound familiar?  Sprinkle in some colorful adjectives and it probably does -- these problems are common enough at clinical research sites.  Equipment and systems have become increasingly technical and specialized, and study site staff has had to contend with more technology than ever before.  And because of the proliferation of niche vendors who provide the new tech, sites have had to deal with more vendors than ever before, too.  

How to Tip Off a GCP Auditor in 25 Words or Less

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.