FDA audit surprise? What to expect, how to prepare
Two IRB coordinators describe the experience
The IRB at the M.D. Anderson Cancer Center Orlando (FL) was given two days last October to prepare for a Food and Drug Administration (FDA) audit. "People tell me a two-day notice is quite common," says Barbara Ward, IRB coordinator. "They called on Thursday and said, Do you want us to come tomorrow or the next day?’" In preparation, Ward pulled charts, made copies, and ensured all meeting minutes and other documentation were in order and waited to answer any questions or requests the auditor had.
Other IRBs seem to have better luck. When Our Lady of the Lake Regional Medical Center in Baton Rouge, LA, had an FDA audit in 1998, there was a week-and-a-half notice. This gave Cynthia A. Harper, IRB coordinator, enough time to audit files to make certain that all 200 of the original protocols and consent forms were included in the files. "We had already gotten our policies in order for an accreditation survey, so that helped a lot," Harper says.
Since IRBs already have to make so many policy and procedure changes to accommodate new regulations, including the privacy requirements of the Health Insurance Portability and Accountability Act of 1996, it’s probably a good idea to have these new policies in place and to be well prepared for an audit long before the FDA calls. "The way things are now, when the regulations change, you go back and change policies again," Ward says. "They’re changing all of the time."
Here are some suggestions for how to prepare for the FDA audit:
1. Audit your own files.
Harper’s extensive audit of all active files included checking the original protocol, consent forms, and the reviewer’s checklist, which contained all of the elements of informed consent, cost benefits, and optional items. Since the 1998 audit, Harper has made certain that the files contain all revised informed consent forms, and everything is held for five years. After five years, it’s sent to an off-site storage. It’s also kept on a database, which makes it easy to review, Harper says.
Every December and July, which are the IRB’s nonmeeting months, Harper conducts impromptu audits on the files to see if there are any discrepancies and to keep track of principal investigators. "I see if there are any delinquencies to get rectified right away and make certain the continuous reviews are in order as they are supposed to be," Harper says.
When the audit reveals that there are missing pieces of documentation, the IRB coordinator should contact the PI and request copies of missing forms, Harper says. "We’re just being proactive and not reactive," Harper says. "I’m just thinking about what might happen and preparing for it in advance."
Ward suggests that audit preparation might include the use of the FDA’s checklist, which can be found on the FDA Web site at www.fda.gov/oc/ohrt/irbs/ by clicking on Appendix H, the FDA checklist.
2. Check IRB meeting minutes.
Ward was told before her audit that another hospital system was asked by an FDA auditor to see the hospital’s IRB minutes from the previous five years. "We prepared for that and went through all minutes back as far as we could go to see if we were missing any," Ward says. If a meeting’s minutes were missing, Ward would ask IRB members to see if anyone had a copy that could be put into the file. Ultimately, the FDA auditor did not request to see all of the previous minutes. "She selected four projects and gave us project names, asking us to give her the files and all of the minutes that were relevant to those projects," Ward says.
3. Prepare to provide protocol files.
In both Ward’s and Harper’s experience the FDA auditor asked to see specific protocol files and all of the relevant documentation. Harper first gave the auditor a list of active protocols that the auditor perused before selecting folders for Harper to pull. "She went through these folders in detail and then said it’d be easier to separate everything out," Harper recalls. As the auditor reviewed the files over several days, she occasionally would ask Harper questions or request additional information. Usually, Harper was able to find what the auditor needed by sometimes checking a computer backup file.
For example, the auditor working with Ward asked to see everything pertaining to certain protocols, so it helped that Ward already had a protocol log established. "We keep a protocol log; a tracking log of projects," Ward says. "We could look on the log and see it went through the minutes of this meeting on this date, and we could pull those minutes for the auditor." The auditor spent some time alone going over the files, occasionally requesting more information.
4. Work calmly with auditor and make changes based on auditor’s comments and final report.
In Harper’s experience, the auditor made a few suggestions, and the IRB received the official inspection observations on an FDA Form 483. "They have all of your information and their information in a table format, showing the auditor’s comments," Harper explains. "They gave us instructions of what we needed to change, but overall, everything was in order." Within 10 days, the IRB sent the FDA a response letter that stated what the IRB would change, and that was the end of the audit, Harper adds.
It’s OK if something’s missing
There was no follow-up inquiry or audit, but the IRB now has documentation of the changes made in response to FDA recommendations, so there should be no problems with those same issues in future audits, Harper says. "If it’s your common practice to keep track of your files and keep everything up to date, then you really don’t have much to worry about," Harper says. "The auditors were very nice and pleasant and not accusatory."
Don’t expect to have everything that the FDA auditor requests, and if you are missing something, simply explain that to the auditor, Ward suggests. "The main thing is to be open and honest," Ward says. "If you’re missing something, you just have to discuss it with the auditor, represent your agency, and be willing to get him or her whatever he or she needs."
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