For a single clinical trial, there are many policies, procedures and practices to keep in order: informed consent, staff members and their roles, adverse events, and investigational plans, among others. Combine that with all the other trials an organization may be running, and it can be difficult to keep everything organized. However, staying organized will help your organization in the long run – especially when it comes to being audited.
While the idea of a Food & Drug Administration (FDA) inspector coming to your site is stressful, understanding an audit’s purpose can put everything into perspective. Audits are conducted to ensure “the trial is conducted in compliance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP) and the applicable regulatory requirements.” If your site is going to be inspected in the near future, it may be nerve-wracking, but it doesn’t mean your site is being inspected for a potential problem.
Types of Audits
In total, there are four types of inspections the FDA may conduct: pre-approval, routine, compliance and for cause.
After an organization submits to the FDA to market a new product, a pre-approval inspection may occur. The inspection will focus on confirming data and making sure the facility is suitable to create the product. The goal of a pre-approval inspection is to gain the FDA’s approval to continue on with the protocol.
When conducting a class II or class III study, your site will experience a routine inspection every two years. The purpose is to ensure everything is still running according to protocol. If there are any risks unveiled during a routine inspection, the inspection can switch to a for cause inspection.
If an organization received a warning letter or had significant 483 observations from a previous inspection, a compliance inspection will be in order. This inspection will be used to address corrective actions, document continuing violations or support future regulatory action.
For Cause Inspection
When a specific problem has been reported to the FDA, they will issue a for cause inspection. Typically, a for cause inspection focuses on the issue at hand, but occasionally, it can cover other issues as well. Different from the other inspection types, for cause inspections are more in-depth since they’re inspecting the site for a particular purpose.
Typically, the FDA will announce both pre-approval and routine inspections five calendar days in advance; compliance and for cause inspections are not announced at all. Regardless of the inspection your organization will face, it’s important to be prepared at a moment’s notice – it will help keep everything organized and everyone on the same page. The less stress your organization faces leading up to an audit will ensure a smoother experience with the FDA.
Want to learn more about how to prepare for an audit? Join us as Chad Adams from the University of Arizona presents, “Top 10 Mistakes Made When Conducting Clinical Research” in our on-demand webinar.