|"Jane, quick! The auditor's here! |
What's an SOP?"
Social Media ManagerPolaris Compliance Consultants
“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.
QA: Hi, I’m here for the scheduled audit of Study XXX. PI: Hey, Jane, did we do that study?
Finding: Inadequate study oversight. Auditor’s Note: Stop sending audit confirmation letters in invisible ink.
PI: Yes, I allocated patients randomly. I let them choose.
Findings: (1) Failure to follow investigational protocol. (2) Inadequate GCP training.Auditor’s Note: Change “Randomized, Double-blind, Placebo Controlled” to “Single-Blind with a Full Twist.”
PI: Meet the staff I’ve delegated the key tasks to: Jim, Karen and… uh uh… what’s your name again, Honey?
Findings: (1) Inadequate study oversight. (2) Staff member does not meet position description requirements.
Recommended Remediation: Honey needs to start spending some serious time on Monster.com.
PI: What’s an SOP?
Finding: Failure to document procedures. Auditor’s Note: “What’s an SOP?” rhymes with 483. Coincidence?
PI: We know how to conduct clinical research. Why should we have GCP training? Besides, I don’t know enough about GCP to train my staff.
Finding: Inadequate GCP training. Auditor’s Note: Wait. What?
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CRC: This is where we keep the drug. Oh, and the milk as well…
Findings: (1) Inadequate/insecure storage of investigational product. (2) Inadequate/insecure storage of frozen blood and urine samples – adjacent to frozen lunch items. Auditor’s Note: Ew.
PI: Well, I ran out of placebo, so I gave them this instead.
Findings: (1) Failure to follow investigational protocol. (2) Mishandling of investigational product. Auditor’s Note: Placebo run-in phase longer than PI expected. Explains stockpile of Tic Tacs in drug storage area.
QA: How did you dose subjects before receiving a supply of the study drug?
PI: The sponsor was slow shipping, my vacation was coming up, so I bought enough drug at Walgreens for 20 patients.
Findings: (1) Failure to follow investigational protocol. (2) Mishandling of investigational product. Auditor’s Note: Does PI get to keep the Walgreens Reward Bonus points? (If so, are these reportable to the Open Payments database?)
QA: Do you know all 20 sub-investigators on the Form FDA 1572? PI: I do not. QA: How do you supervise them? PI: They are professionals and I assume they know what they are doing. If it’s not broke don’t fix it.
Findings: (1) Inadequate study oversight. (2) Inadequate training. Auditor’s Note: Well, guess what. It’s broke.
Do you have any tales about obvious compliance red flags you want to share below? Don’t forget to de-identify!
Laurie Meehan has been with Polaris Compliance Consultants, Inc. since 2008, writing SOPs and managing a variety of internal and external projects related to training, technology, social media, and documentation. Prior to joining Polaris, she worked at a major telecommunication research and development company where she wrote requirements for telecom services and products, and spoke at numerous industry forums. Ms. Meehan also teaches math at a local university and tutors high school students in math and SAT prep. Ms. Meehan holds a Bachelor of Arts degree in computer science from La Salle University and a Master's degree in computer science from Drexel University. She can be reached at firstname.lastname@example.org