Written by Nicole M. Palmer and John R. Nocero

Inspections are the apex of the clinical trial. It is something that study teams prepare for, plan for and ultimately get nervous about when they are going on. If you haven’t ever been through an inspection before, here’s what you should expect, according to the FDA. Usually, the inspector examines processes, and protocol adherence reviews documents and records, and issues observations when they are done. Being audit ready doesn’t mean always being 100% compliant; that’s unrealistic. Being audit-ready means being prepared – coming through the inspection in the best way. This could be instilling an internal monitoring program, quality assurance, or quality control activities after the inspection to remedy findings; being able to develop corrective and preventative action plans quickly and with precision. Having internal processes in place to identify patterns of errors or knowing why procedures consistently fail. You’ll also know if retraining isn’t working, and why blaming the previous research coordinator (who’s gone on to another gig) doesn’t always work. We’ve heard people say that staying audit-ready takes time. It does, but it is time well invested and money well spent.

Do you really want to incur financial, reputational, and institutional costs if you are not prepared?

3 Tips to Help you During an Audit

1. Remind all staff to review the company’s Standard Operating Procedures (SOPs) regarding Sponsor Audits and Regulatory Inspections.

2. The auditor should be always accompanied. All desks/office space must be clear of confidential information. Cabinets and doors must be locked. Paperwork must be concealed and computer screens on screensaver mode or turned off when not at your desk.

3. The auditor may be given a tour of the offices and IT room. I reiterate that all procedures referred to your company’s SOPs are being always followed.

With that said, what does it mean to be always inspection-ready?

It means to have internal processes put into place and follow them without much preparation prior to the inspection. This is an ongoing process throughout the trial. Your company’s SOPs and Trial Master File (TMF) Plan will clearly define and outline these processes. Your SOPs should outline who is responsible for each task and ensure that each person that is assigned to that task will be consistent guaranteeing uniformity of operation.

Mock internal inspections are crucial to being inspection ready. You want to ensure that all staff members are following ALCOA Plus principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring and Av,ailable) when they are reviewing documents prior to placing them in the TMF. Based on the table of contents that you are using for your file structure, are the documents filed in the appropriate locations? Are documents being filed in a timely manner based on your SOPs? Does your TMF paint a picture of where the study currently is? Can you find the missing gaps if there are any?

 If you are having an FDA audit, some possible reasons why you might receive a 483 could be due to lack of time, staff turnover, lack of training, failure to follow the protocol, protocol deviations, inadequate recordkeeping, and inadequate subject protection. However, if you do not receive the FDA Form 483 do not ask for one! This is a good thing if you didn’t get one. Regardless of the outcome, there is always something to be learned. Positive or negative. Even if it’s a negative, this is your opportunity to turn it into a positive the next time around!

How do you preach audit readiness to your team?

As always, if you have a question or want to leave a comment, please feel free- We are happy to help and love to hear from you.