“I just got a message from someone at the FDA. He said he works for By Mo and wants to schedule an audit. I don’t know what By Mo is, so I thought I’d better contact you first:’
Jill Casey had just returned from her honeymoon and was trying to catch up on email. Jill chuckled at Dr. Silver’s spelling of BIMO but, as the study monitor for Dr. Silver’s site, she knew that the auditor’s call was no laughing matter. She picked up the phone and called Dr. Silver.
“Hi, Dr. Silver. This is Jill. I just read your email. What else can you tell me?”
“Welcome back. My email is all I know. Some guy named Thompson left his name and number and said to call as soon as possible to schedule the audit. What should I do?”
Jill said,”First, don’t panic. Remember, during study training, we mentioned that any site could be audited at any time. The audit will be conducted by an inspector from BIMO, spelled “B-1-M-O;’ which stands for the Bioresearch Monitoring program. There are many reasons the FDA might audit. It could be routine or it could be because something in the study data that the sponsor submitted didn’t look right:’
Dr. Silver interrupted. “But we did everything right. You even told us that yourself. So, why did the FDA pick us?” Jill sighed. “The FDA is not the enemy, Dr. Silver. They are responsible for making sure that every study was conducted according to the protocol, GCPs, and the Animal Welfare Act. They want to verify that the data were properly collected, accurately recorded, and fully reported:’
“But why pick a site that did everything right? Why not one with lots of problems?” “We know that you did everything right;’ Jill answered, “but the FDA doesn’t know that. And, for all I know, they may be auditing every site. But, for now, we just need to get you ready. If you have some time now, we can go over a few things:’ “That’s fine with me;’ Dr. Silver said.
Jill logged in to the electronic data capture system and called up Dr. Silver’s file. “Let’s review the study. You and Melanie attended the investigator’s training meeting and you both signed the attendance sheet. You both completed training on the study’s EDC system and those certificates were uploaded. The test article arrived in two shipments which Melanie signed for and counted. I personally reconciled the test article inventory with Melanie during each monitoring visit, so I know those reports a re correct. You enrolled 1 S dogs, which was higher than any other site, but still within the protocol’s limits. And each owner signed a consent form before any test article was dispensed. From what I can tell, your file is in perfect order:’
“You can verify all of that?” asked Dr. Silver. “Oh, yes. It’s all in the EDC. Every entry you or Melanie made was date- and time-stamped. So, there’s no question that you followed the protocol:’
“So, is there anything I need to prepare?” Dr. Silver asked. “Not really. Once you confirm the date and time of the audit, call me. I’ll come out the day before so you, Melanie, and I can review the study binder together and confirm that all your documents are in order. After that, we can discuss questions that might be asked. I suspect the sponsor might send someone as well:’
“That’s wonderful. I feel a little less nervous now. Have you been through an audit before?” “Oh, yes;’ Jill replied. “The first few audits made me nervous, too. But now, after about fifty of them, I’m fairly comfortable. I’ll keep a log of all the questions the inspector asks, and the answers, as well as which documents the inspector requested. Then, I’ll prepare a report of the audit for you and the sponsor. I don’t want to create a false sense of security, but I’m pretty sure you’ll come through with flying colors:’
“I hope you’re right. I’ll call Mr. Thompson now and let you know when the audit is. Thanks for your help:’ Jill hung up and called the sponsor’s project leader to inform her of the upcoming audit. Then, she pulled out her audit checklist to remind her of all of the things she would need to prepare before flying out to Dr. Silver’s clinic.
Later that week, as Jill’s plane began its descent, she felt relatively relaxed because Dr. Silver and his staff had done such a great job on the study. She wished that all of the other sites had been as good, and she wondered if any of them would be audited as well. But then her thoughts drifted back to her wedding, the wonderful honeymoon, and an exciting life ahead with her new husband. She closed her eyes and smiled.