Hand in hand with her new husband, Jill Casey was walking the beach at sunset when a bumpy landing woke her from her honeymoon daydream. “Back to reality;’ she thought as she collected her things from the seat pocket. A few days earlier, she had received an email from Dr. Silver telling her about a call from ‘By Mo’. After explaining what Bioresearch Monitoring program (BIMO) was and what the inspector might want to see, Jill promised the anxious veterinarian that she would help the clinic get ready.
Jill arrived at Dr. Silver’s clinic right after they opened and was greeted by Melanie, the receptionist. “I’m so glad you’re here, Jill. Everyone is frantic! Go right into the lunch room and I’ll let Dr. Silver and the others know you’ve arrived:’ Jill went to the lunch room and made herself some coffee as the staff trickled in.
After everyone had grabbed a chair, but before Jill could say a word, Dr. Silver exclaimed: “I remember you telling us that we could get audited at any time but I didn’t register that it could be by the FDA! Why would they pick our clinic?”
Then Mary, one of the technicians, chimed in: “What if the inspector asks us something we can’t answer? What if he finds something he doesn’t like? Will we be in trouble?”
“And what if I can’t remember something?” added Dr. Silver, “After all, we finished the study three months ago:’
Jill put down her coffee and raised both hands high. “Everyone needs to take a deep breath and relax. You did a great job on the study, so nothing bad is going to happen. And I’m here to help you prepare. So, let’s talk about what happens during an audit and who’s going to do what:’
“Remember, the FDA is not the enemy;’ Jill continued. “They make sure that every clinical trial was conducted according to the protocol, GCPs and the Animal Welfare Act. They verify that all data were properly collected, accurately recorded, and fully reported:’ Jill looked at each of them as she spoke. “You did that, so you have nothing to fear:’
“If we didn’t do anything wrong, why did they pick us?” Mary sighed. Jill responded: “Sometimes I have a pretty good idea why a site is chosen – lots of protocol deviations, adverse events, or some other problem. But sometimes, the FDA audits every site. You could just be the first site to get audited. Whatever the reason, I think you’ll pass with flying colors!”
Dr. Silver’s brow furrowed as he asked: “What should we say or not say?” “Just be honest;’ advised Jill. “Answer every question as best as you can. If you don’t remember the answer, say so. Then ask the inspector if you can review the study file to refresh your memory. The inspector understands that the study ended three months ago:’
After more discussion, the group agreed to be at the clinic by 8:00am the next morning. Jill stayed to look through the study binders and then did a quick tour of the clinic with Dr. Silver and Melanie. Amy, who was the study dispenser, was waiting at the door when the inspector arrived at exactly 9:00.
“Hello. I’m Mike Thompson with the FDA’s Bioresearch Monitoring Program:”
Amy introduced herself and then escorted Mike to the lunch room, where all of the staff were waiting. After introductions, Mike asked each member of the study team for their title and role in the study. He also requested a history of the clinic and how it was organized. Dr. Silver answered these questions and then offered to give Mike a tour.
“Not yet;’ Mike said. “But I would like to see where you stored the test article:’ On the way to the medication room, Mike asked Dr. Silver about his training and experience in clinical research.
Dr. Silver sheepishly said: “This was my first clinical trial. I hope we did everything correctly:’
“We’ll soon see;’ replied Mike.
Dr. Silver explained the process for receiving the test article, counting doses and documenting the relevant information on the study form.
“Who had keys to the medication room?” Mike asked.
Amy answered: “Dr. Silver and I are the only ones who have keys. During the study, I was the only person who had a key to the locked drawer that contained our study Drug:’
“Good;’ said Mike, “the test article is experimental and must be kept separate and secure from the rest of the clinic’s medication:’
“We understand that;’ said Dr. Silver.
“I’d like to see a copy of the test article storage temperature log. Where would I find that?” asked Mike.
Dr. Silver thought for a moment. “We didn’t record a daily temperature;’ he said. Amy added: “The protocol didn’t have a temperature log, so we didn’t record that:’ “Is that a violation?” Dr. Silver asked. Mike clicked his pen a few times. “No, it’s not a violation. It’s just that if the protocol includes a test article storage temperature range, it needs to be recorded to document your compliance. The fact that the protocol did not include a data form is not your fault, so I will not cite you for not recording it. However, if you participate in another clinical trial, and the protocol includes a test article storage temperature range, ask the sponsor where to document it:’
When Mike returned to the lunch room, he asked Jill what her role was. Jill explained that she was the study monitor. “I visited the clinic every six weeks. During each visit, I verified the test article inventory, reviewed the study binder and confirmed resolution of all queries. If the staff had questions, I answered them and then documented that discussion in the study file:’
Mike nodded and turned back to Dr. Silver and Amy. He asked about their duties, hours of operation and the source of their study subjects. He then retrieved a copy of the study report from his briefcase and opened it to a flagged case. “When I reviewed case number BEA-002, I couldn’t find an end date for the temperature adverse event. Was this not resolved before the dog finished the study?”
Dr. Silver remembered exactly what happened. “That dog’s temperature was elevated at the final visit. I noted it in the EDC as ‘unresolved’ and added that I would follow up with the owner. The owner called that evening and said her dog’s temperature had returned to normal, but she would check it again in the morning:’ “And did you follow up with the owner?” asked Mike.
“I called her as soon as I arrived at the clinic;’ replied Dr. Silver, “and her dog’s temperature was normal:’ Mike then asked: “Did you include your extra note in the EDC?”
“Oh, no!” exclaimed Dr. Silver. “Was I supposed to?” Mike answered: “No, you didn’t need to add it. But, in future studies, you should discuss any adverse event that remains unresolved with the sponsor and get their direction:’ Mike had a few more questions as he reviewed the rest of the cases. Finally, he took off his glasses, looked up, and said, “Considering this was your first clinical trial, you did a very good job. I have no findings. However, I’ve given you several suggestions for future clinical trials and I recommend that you follow them:’
The tension immediately evaporated from the room. Jill signaled to everyone with two thumbs up. Dr. Silver winked back at her as he mouthed “thank you:’ After Mike packed up his briefcase, Dr. Silver and Jill escorted him to the door. They all shook hands and Mike headed toward his car. He looked back over his shoulder and said, “I hope all of the other sites are as well-organized as you were:’
Just then, Jill’s cell phone rang.