You just got the phone call; the Food and Drug Administration (FDA) Inspector is coming for a visit.
Are you feeling calm and prepared, or like most people in your position, are you in some stage of panic? After all, who wants someone from the federal government looking for (and inspecting!) all the things you might have done wrong?
Don’t let anxiety get the best of you – begin preparing now.
In 2015, FDA conducted over 1,000 Bioresearch Monitoring (BIMO) inspections, of clinical investigators, IRBs, Sponsors, and CROs. Of those inspections, around 60% came through with no findings. Clearly, most clinical research entities are doing something right. But you’re worried about being part of the other 40%.
Luckily, a recent article in the 24th Issue of Medtech Insight provided five tips for a successful inspection from the experts that attended the 11th annual FDA Inspections Summit in Bethesda, Maryland in November 2016.
- Have Inspection Procedures in place: Standard operating procedures (SOPs) describe what to do and when to act appropriately.
- Notify all key stakeholders of the upcoming FDA inspection as soon possible. This may include the Principal Investigator, Management, research personnel involved in the study, the IRB, and/or the Sponsor.
- Locate your institution’s/company’s FDA Inspections SOP. If your institution/company does not have one, it may be helpful to consult someone to create one to ensure everyone is prepared.
- Review the SOP and note all applicable action plans. This should cover every step of the inspection, including inspection preparation, arrival of the inspector, conduct of the inspection, and the exit interview.
- Provide Adequate Workspace: The set-up for where the inspection will be held should ensure there is privacy and enough space.
- Locate a designated area for the inspector to work. It’s important to not put them in an office where they might have access to information outside of the scope of the inspection. The key is an empty space that is quiet and comfortable. A conference room is usually an appropriate place.
- Remember you are the host—be polite from the time they arrive to the time they leave.
- Ensure the Appropriate Staff Interact with Investigators: Key stakeholders must have the right experience and communication skills.
- Know who the key stakeholders are at your institution/company, because they are ultimately responsible.
- Determine who will facilitate the inspection. This should be someone who has the ability to keep calm and speak to any concerns and/or requests.
- Select Subject Matter Experts Carefully: Experts should not only have a thorough knowledge of the matter, but also the skills to communicate efficiently.
- Determine who the expert(s) are that can answer questions in a concise and clear manner. It is best to avoid using someone who “over-shares”. If the answer is not immediately known, let the inspector know that you will find the answer for them (and do it promptly). Do not speculate. Answer only what is asked.
- Use Roleplaying: Choose someone who isn’t afraid to play the part and will tell you how it is before it happens.
- Ask someone to review your records and ask for honest feedback. Consider planning and conducting a mock inspection. You want to prepare yourself and those that are going to be the key players in the real deal.
How do you feel now after going through these preparation tips? Do you feel more prepared than before? Do you need additional tools and resources to help you and your institution/company prepare for an FDA inspection? Find out how IMARC can help prepare you here.