March 18, 2019
BIMO Inspection Readiness Checklist & Guide: FDA BioResearch Monitoring of Clinical Trials
Did you know that an FDA inspector typically schedules a bioresearch monitoring (BIMO) audit within five days of arrival? Would your clinical have BIMO inspection readiness in such a short time?
Well, it should be: these inspections can occur at any time during a clinical trial, and there is no hard rule for how much notice they have to provide.
If you are wondering what a BIMO inspection entails and how to best prepare, you have come to the right place. We will cover all of this and more in our BIMO inspection readiness guide.
What Leads to a BIMO Inspection?
BIMO inspections occur randomly. This ensures the safety of human research participants. It does not mean that you are doing anything wrong.
But there are certain items that make a site visit more likely. For example, if you are a very high enroller, you are more likely to experience an inspection.
And remember that warning is a courtesy, not a necessity. If the FDA has been provided with information that raises concern, such as subject protection, data integrity, or a history of problems, they are more likely to show up at your site unannounced.
What is a BIMO Inspection Like?
A BIMO inspection has three purposes: to ensure human research participants’ rights, welfare, and safety, to determine the trial data’s accuracy and reliability, and to check for FDA regulatory compliance.
Most inspections are of clinical investigators, although hired contractors, Institutional Review Boards (IRBs), and nonclinical laboratories can also be subject to FDA inspection. BIMO inspections are entirely different from manufacturing inspections, which are more a common type of FDA inspection.
A BIMO inspection can last anywhere from 2 to 10 days. Upon arrival, the field investigator will tell the principal investigator what is going to be reviewed and will request a list of all studies performed by the investigator. They will also review regulatory documents, subject case histories, and other study records such as data collection practice and data security.
Throughout the process, the inspector will ask questions about the protocols and the regulatory documents.
They will also check that your equipment is FDA compliant, so be sure that your biological products are using an FDA compliant temperature monitoring system and that you have an FDA compliant CO2 monitor in place.
At the end of the inspection, the investigator will have a meeting with the principal investigator. The results can be no written observations, a list of observations that are in violation that must be corrected and responded to within 15 days, or a warning letter for when serious violations are found.
Most Common Deficiencies
Luckily, the FDA provides a list of common deficiencies, so you what to look for when preparing for BIMO inspection readiness. These are the most common deficiencies for clinical investigators:
- There are deviations from protocol.
- Record keeping is inadequate.
- There is poor communication with the IRB.
- You are not following the investigation plan and/or regulations.
- There are problems with subject protection.
- There is not enough accountability for the product being investigated.
- The product is represented as safe or effective.
Here is a list of the most common bioequivalence deficiencies:
- Record keeping is insufficient
- There are problems with inclusion and exclusion criteria.
- There are dosage problems.
- There are problems with validation and stability of data.
- There is a problem with reserve samples.
- There are problems with informed consent.
Finally, here is a list of good laboratory practice deficiencies:
- There is a problem with organizing or personnel.
- There is not enough archiving.
- There are not any study records, or they are incomplete or inadequate.
- There are problems with standard operating procedures.
- There are deviations from protocol.
Keep these items in mind when preparing for your next BIMO inspection to be ahead of the game.
BIMO Inspection Readiness: A Checklist
If you keep track of the items on this list, your inspection is bound to be a success.
- Don’t allow protocol deviation, unless it is a matter of safety. Since protocol deviation is one of the most common deficiencies years after year, it is especially important to stay on top of this.
- Practice regular communication. Your site has to be in constant contact with any monitors, vendors, and sponsors working with you on the study. There should be no barriers between any of these groups for optimal success.
- Have well-trained monitors. These monitors should conduct internal audits throughout the clinical trial. Make sure they know the regulations so that they can be on the lookout as well as offer support.
- Set up a master file. Make sure to include all essential documents as they get created, as well as any additional changes. Since record-keeping is another frequent deficiency, this is extremely important.
- Have a training session just prior to inspection. Although you may only have a few days, it is good practice to refresh staff on the BIMO audit process before the inspector arrives. This makes sure that everyone is on the same page and has the most updated training.
- Keep documentation of any problems. If there are any corrective or preventative actions, be sure that you document all communications and resolution steps. If there are any adverse events, be sure to report them per the protocol.
- Create strong yet realistic standards of practice. It is essential to have a good set of standards of practice. But take care not to make them too stringent, or you run the risk of not sticking to them.
- Check over the guidelines one more time. The Compliance Program Guidance Manual has in it everything you need to prepare for your inspection, so be sure to look it over just before the inspection in case there’s something you happened to forget.
Following this checklist gives your clinical trial a great chance at passing the BIMO inspection with flying colors.
Now You are Ready for Your Next BIMO Inspection
Hopefully, this checklist has made you feel like you have BIMO inspection readiness.
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Check out our list of products for biopharmaceutical groups, and please contact us if you have any questions about the items and services we offer.