Next time you have an encounter with an FDA inspector, don’t be surprised if they really know their stuff. In a policy shift, the agency is working to make its inspectors more specialized. It’s becoming less likely that your inspector “will come to your facility and then go to a factory the following week,” Chavon Steele, Senior Clinical Trial Monitor at Medtronic, told attendees at the ACRP 2016 Meeting & Expo in Atlanta today. She’s also a former FDA inspector.
While the FDA only inspects about 1% of all clinical trial sites each year, it’s still important to know how to prepare for the prospect, Steele said. Another point to consider, when FDA comes calling for an inspection with cause, your only notice will be if you happen to see them pulling into your parking lot. Even routine inspections can come with as little as one week notice, she pointed out. About 75% of inspections are of the routine variety.
When the FDA informs you they’re coming over to kick the tires, savvy CROs need to ask several questions, including:
- How many inspectors will participate?
- Which clinical trial(s) will be inspected?
- Which location(s) will be inspected? For example, are they going to a satellite office or an outsourcing facility that does blood work for you?
- Who on your team should be available and what documents should you be prepared to offer up at the outset?
Taking a closer look at document collation, Steele said to include all versions of the study protocol and informed consent, the investigator brochure, delegation log, evidence of training on the study, financial disclosure forms, signed informed consents, and the source documentation and medical records relevant to the clinical trial.
It’s also important to arrange for an adequate work space for the inspector, Steele said. For example, keep it away from a busy area. Reason? She’s seen situations where an inspector overheard staff talking in a nearby hallway. Sometimes, those comments, especially taken out of context, can change the whole focus of the inspection — and not necessarily to your benefit.