In clinical research, it’s inevitable: your site will face an audit at some point. While it’s easy to let emotions run high during this time, it’s important to remember audits are a part of the process and help ensure ethical clinical research is conducted across your site.
There are many things to do ahead of time in preparation of an audit that can help ease the tension. Putting in the work upfront may initially create more tasks, but it will be worth it in the end as it will help make the process more seamless. Here are some things to keep in mind as your organization faces an audit.
One of the most important things you can do before and during an audit is to stay calm, which is often easier said than done. It’s much easier to gather all necessary materials and documents with an open mind, rather than frantically sifting through materials. A panicked approach means there is more room for error, making it more likely that you’ll misplace something or forget it altogether.
More often than not, audits are prompted at random and are a result of routine protocol by the Food and Drug Administration (FDA). If a site has a New Drug Application (NDA), the chances of experiencing an FDA audit are higher, since it is the final step for approval of a new drug.
Audits may be targeted, too. Sites that have high enrollment of participants will most likely trigger an audit, for example. If a complaint is filed against a site, that could also warrant an audit to address the concerns presented.
When an auditor comes in, they are going to be nitpicky because they want to make certain that you know the site and the studies you’re responsible for in their entirety. Before the day of the audit, take time to become familiar with every aspect of each study – the protocol guidelines, your tasks and your team members’ tasks. This will help show the inspector that not only do you know your studies, but you are also complying with the protocols as well. While this may seem like an extra step, knowing these aspects of a trial prepares you for the audit, and makes it easier to keep trials on track as time goes on.
While using a clinical trial management system (CTMS) helps with day-to-day tasks, it will also come in handy when preparing for an audit. Using your CTMS allows research staff to better track important documents, such as IRB reviews or informed consent forms (ICFs). By having documents like these accessible and in electronic format, you’re given immediate access to them, making it easier to pull them up for the auditor.
A CTMS also helps keep an accurate count of the drugs being distributed – to whom they were given and when. Updating the records in real time ensures the counts are accurate at all times, especially during the audit.
While audits can put research staff in a high-stress position, it’s critical that a site’s audit comes together for the FDA – the success of the trials, as well as the site as a whole depends on it. There are many moving parts to consider when preparing for an audit, however, keeping these three tips in mind can help you and your staff in the long run.
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” on Tuesday, December 10 at 12:00 pm Central.