SAN DIEGO—You come to work. The day is going well. Your clinical trials are moving along. Then you get the call: It’s the Federal Drug Administration (FDA), and they’re coming to audit in about a week.
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Explore This IssueFebruary 2018
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You might be struck by a sense of dread. But you don’t have to be, an expert said at the 2017 ACR/ARHP Annual Meeting Nov. 3–8. You just have to be prepared.
“If you prepare every day, you’re going to be just fine,” said Lisa Kastanek, RN, research coordinator at Nebraska-based Physician Research Collaboration in Lincoln, Neb., a company that helps run clinical trials.
A good place to start: Read and know the FDA’s Compliance Program Guidance Manual. It’s like “the answers to the test,” Ms. Kastanek said. “It gives you a rundown of what they’re looking for, so you can develop a site-readiness plan.”
Ms. Kastanek also offered these tips for your daily practice to remain prepared for an audit:
- When preparing documents, adopt the ALCOA approach: attributable, legible, contemporaneous, original and accurate. That means it should be clear who wrote the document; it must be clearly written (Kastanek mentioned dates specifically as a potential legibility problem); the document should be written at the time of the event; the original documents must be available; and the information in them should be correct.
- Avoid “notes to file.” Documents shouldn’t refer to the file, because “I don’t want them to go have to look somewhere else and find more information about it.”
- Set up protocols properly with thorough protocol review and identification of protocol discrepancies. “Setup of protocol is very labor intensive, but it’s the most important piece.”
- It’s especially important to have, and consistently follow, practice standards for key areas, such as informed consent, training, investigational product, quality assurance and data checks. “It’s a whole lot easier to answer FDA questions when you have and follow consistent standards,” Ms. Kastanek said.
- When preparing for one audit, keep in mind future audits and make adjustments if necessary.
- Although sponsor audits don’t duplicate FDA audits, they can offer a hint of what the FDA will look for.
It’s a whole lot easier to answer FDA questions when you have & follow consistent standards. —Lisa Kastanek
At the time of the audit, Ms. Kastanek offered these tips:
- Make sure the person who answers the phone knows where they should route FDA calls.
- At the time of the call, find out the reason for the audit. Is it an inspection for cause, for example, or a routine audit? And note which regulatory office originated the call—your sponsor might want that information.
- Establish an inspection team. “We need to make sure everything is organized to a T because the more organized it is, the faster the FDA can review it and the sooner they can [finish].”
- Delegate one staff member to lead the audit and work with the inspector the entire time. Ms. Kastanek said it’s best to limit the number of people with the auditor, and whoever interacts with the inspector must know everything about their part of the clinical trial.
- Review every informed consent form with great care. “That means every page of every ICF,” making sure they’re all signed, and that every spot for initials has actually been initialed.
- Know the details of all serious adverse events and adverse events of special interest, inside and out. “You’ve got to know what happened in those situations.”
- When answering questions, try to get the auditor to narrow the focus so that you can avoid “an unnecessary, potentially lengthy discussion about the process.” Don’t answer a question if you’re not 100% sure of the answer. And keep answers succinct to avoid going down a rabbit hole.
- Remain friendly, but remember, the FDA is “not your friend,” and avoid the trap of saying something inappropriate.
- Set aside an area for the auditor to work that’s away from patient and staff conversations.
- Stay with the auditors often so that “they themselves don’t answer questions with the wrong answers,” suspecting something is wrong when it’s just a misunderstanding.
- Use daily wrap-up meetings to address any FDA concerns, and update your sponsor at least once a day.
- If the auditors issue a Form 483 with suspected violations, make sure you understand the reason so you can provide a response. A response will be required within 15 days.
Last, Ms. Kastanek emphasized the importance of consistency. “Standards driven by regulations, followed every day, are key to inspection success,” she said.