FDA practice audits help researchers keep calm, carry on
There are few things more anxiety-producing to a biomedical researcher than a surprise audit from the Food and Drug Administration (FDA). The FDA conducts four different types of audits — pre-approval inspections, routine inspections, compliance follow-up inspections, and “for cause” inspections. Each is intended to help protect the public from unsafe medical research and products, and to ensure that research is being conducted in compliance with laws and regulations. For researchers at academic medical centers, audits are disruptive. In a worst-case scenario, FDA inspectors might issue a warning letter or shut down a study for safety reasons.
To help researchers prepare for audits and improve research procedures, Stanford’s Clinical Research Quality (CRQ) office currently offers a free service, a mock FDA audit, upon request.
The mock audit process
Megan Saeedi, a Certified Quality Auditor (CQA) with 17 years of auditing experience, is CRQ’s go-to person for conducting mock audits. She has worked as a quality auditor at eight companies, including Boston Scientific, Johnson & Johnson, and Boehringer Ingelheim. She’s been at Stanford since 2017. And she’s a stickler for details.
While a real FDA audit might take four to five days, Saeedi’s mock audits are condensed into one. When she arrives, wearing a suit and the professional demeanor of a real FDA auditor, she walks through an investigator’s lab to the designated audit room, taking mental notes on the cleanliness of the workspaces and potential breaches of private health information. After settling in, she asks the study spokesperson questions that a real auditor might ask:
“Can I tour your drug accountability storage area?”
“Could I see the ledger that accounts for dosages administered?”
“Tell me about the training that your clinical trial coordinators receive.”
“Show me your records on research subject adverse effects.”
She may visit the pharmacy where investigational drugs are stored. Or ask to see where consent forms and patient records are kept. She takes notes on “observations” that will be discussed later.
At the end of the day, Saeedi’s virtual armor comes off and she sits down with the study team to discuss her findings. First, she walks them through her slide deck, “The Do’s and Don’ts of FDA Audits,” discussing how the team rated in each area. She emphasizes that the mock audits should be viewed as learning experiences, not personal critiques.
“We don’t audit people. We audit processes,” says Saeedi. She explains that CRQ’s primary goal is to teach the team how to establish procedures and systems that efficiently produce desired research results.
Her most common advice to “audit newbies” is that less is more when it comes to answering an inspector’s queries. Reply succinctly with no embellishments. If you don’t know the answer to a question, don’t guess or speculate. Above all, never argue with the inspector or blame someone else for mistakes. Show the auditor only the records requested, so that collateral observations are minimized.
Support for real audits
CRQ’s director, Jennifer Brown, RN, says that if you find yourself facing a real audit, don’t panic — CRQ is there to help. Staff members can prepare your team for external audits by the FDA, an industry sponsor, the National Institutes of Health or other funding agencies.
Even with a surprise audit, you may have a week to prepare. Saeedi can assist your team in developing a game plan for the visit. She’ll coach your designated spokesperson on how to approach queries. She’ll review study records to make sure that they are well organized for the auditor. She’ll do a site inspection and identify areas that need to be addressed before the audit.
Brown adds, “We coach investigators to demonstrate that they’re in control. That they know where everything is. That their records are in order. That they can answer audit questions quickly. If it takes three days to answer a question, it might raise red flags.”
If by chance the FDA submits observations about conditions that they think are objectionable, a CRQ staff member can help you respond within the expected FDA timeframes.
Other CRQ services available to Stanford investigators include:
- Consulting audits for industry-sponsored trials, a free service that might cost a study team thousands of dollars if an outside consultant was used.
- Compliance advice during an external audit.
- Assistance in responding to a corrective and preventive action (CAPA) plan following an audit.
- Quality reviews of study records.
“CRQ especially wants to do a better job of supporting investigators who are conducting their first industry-sponsored study,” adds Brown. “It’s those researchers who may be at more risk, but with our training, issues are avoidable.”