If it takes a regulated entity too long to retrieve requested documents during an inspection, U.S. Food and Drug Administration (FDA) agents sometimes “begin to wonder if something [suspicious] is going on,” Eric Pittman, Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs, warned attendees of ACRP’s 2022 Conference in Orlando this week.
Ideally, a site has its documents in order and various ducks in a row before the inspector is sitting in reception or knocking at the front door, but Pittman said the next best scenario is quickly telling the inspector the situation. “Don’t delay unnecessarily, if time is needed to retrieve records or find an answer to a question, explain why,” Pittman said.
Also, be ready during the inspection to explain your record-keeping logic, organization, and access, Pittman said. It’s wise to “be accessible to answer questions and provide copies” or help with any inspector request, Pittman added.
There is an underlying mission driving the agency, he said. FDA is committed to protecting the health and rights of human subjects, Pittman reminded attendees. “Remember, these treatments are for people, and there’s a person at the end of that application who will be taking that medicine or treatment,” he added.
Grace Wentzel, senior clinical research director at Nationwide Children’s Hospital, takes Pittman’s point to heart. She’s a big fan of diligent record-keeping and documentation.
There are a number of compelling reasons to get documentation right but reducing compliance issues is right up there near the top of the list, Wentzel told attendees of ACRPs 2020 Conference.
“If your records aren’t ready before FDA calls” to say they’re coming in a few days for an inspection, “you won’t be ready” when they show up, Wentzel said.
She challenged sites to take a more proactive approach to the issue. “Too often sites rely on monitors to identify their mistakes,” she said. Getting a better grip on documentation “helps you to catch you own mistakes,” Wentzel said.
Author: Michael Causey