Audits are an important quality assurance step for ensuring safety and compliance in clinical research that complement the quality control activities such as monitoring.
Virtual audits have become increasingly common in the past year as more sponsors and sites look for ways to keep their trials moving forward in the midst of the pandemic. Although a virtual audit is often more convenient and cost-effective, it comes with additional considerations.
Here’s a closer look at the benefits of conducting a virtual audit and how to prepare for one.
What Is A Virtual Audit?
A virtual audit follows a similar process to an in-person audit, but the process takes place electronically through video-conferencing and secure file-sharing platforms. The link is usually shared with the auditor and other personnel that might aid the audit process.
The auditor works their way through their agenda and questions, and will ask you to share the relevant documents and data. Items may be shared on-screen, via direct platform access (eTMF, EDC, EMR), via secure file sharing, or a combination. Specific activities will vary depending on the type of virtual audit. For instance, a site GCP audit will focus on subject records and investigator files to assess compliance with clinical research regulations, the protocol, IRB and sponsor requirements. A sponsor or contract research organization (CRO) audit will look at the whole study to assess compliance and oversight. If the audit is specifically in preparation for a potential inspection, it will determine your team’s preparedness, such as for a BIMO FDA inspection.
A remote or virtual audit is particularly critical now, but it has other benefits beyond the pandemic. Here are a few reasons why you may opt for a virtual audit.
Normally, an on-site audit requires extensive reviews of your clinical trial documents for several days. The in-house team has to spend time working with the auditor, which halts other critical activities. With virtual auditing, you can simply authorize auditor access to your clinical trial documents and let them work at their convenience, and reconvene for further discussion.
On-site audits often involve substantial costs. For instance, during a Trial Master File audit, auditors may need to be present for several days and require travel expenses, accommodation and meals during that time. Virtual TMF audits eliminate these additional expenses, which could potentially reduce the total cost by as much as half.
Auditors who are knowledgeable in BIMO inspections and FDA regulations understand what inspectors look for and can structure their strategies accordingly. While reviewing your documents electronically, they will identify any data discrepancies, potential violations, and protocol deviations that would lead to an FDA warning letter. Because auditors have more flexibility during a virtual audit, they can focus their attention where your team needs the most help. They can catch issues you might have missed and prepare you to pass your next inspection with confidence.
More Training Opportunities
Besides ensuring compliance, virtual audits also identify improvement opportunities. For instance, your auditor might recommend changes to your standard operating procedures or clinical research training to help your team become more competent in specific areas.
How to Ace Your Next Virtual Audit
A virtual audit isn’t necessarily faster or easier than an in-person audit, but there are potential efficiencies and advantages. To get the most out of your next virtual audit, your team still needs to plan and prepare ahead of time. Follow these best practices to ensure success.
Set Up Your Video Conferencing System
If it's your first time working with the auditor, find out which video conferencing system they prefer and make sure your team is familiar with it ahead of time. Make sure you can confidently navigate the platform, share your screen, and collaborate easily with all relevant individuals.
Choose A File-Sharing Platform
Virtual audits involve sharing massive amounts of data and files, so you’ll need a secure file-sharing platform to streamline this process. There are many file-sharing platforms available with varying prices and functionality, and your auditor may have an option ready to recommend.
As you consider your options, make sure the platform you choose aligns with data privacy requirements outlined in HIPAA.
Prepare Your Audit Documents
Ask the auditor for an agenda and a list of documents they plan to review so you can ensure you have everything ready.
This will vary depending on the type of virtual audit they are conducting, but you should expect to have the all essential documents available for reference for your study and organization.
Having these readily available in your file-sharing system will help your virtual audit go more smoothly. This is also a good time to make sure your documents are organized in folders with file names that use consistent naming conventions.
Maintain Effective Communication
Good communication starts with the audit’s opening meeting, where you will discuss the purpose of the virtual audit, timeline, and next steps. First, confirm the auditor can hear you clearly and see you on camera. Make sure they can also see the documents you are sharing on your screen and have access to the systems to be used.
During the kickoff call, you will also want to establish a cadence for follow-up communication. For instance, what is the best way for the auditor to reach you with questions as they review your documents? At what point during the audit should you reconnect to discuss the findings?
Guide The Auditor Through The Documents
You are very familiar with all your documents and where to find them, but the auditor isn’t. That’s why it’s a good idea to introduce them to each document and its location on the opening call.
One way of doing this is by sharing the screen and opening files directly from your file-sharing platform. It may also be helpful to give them a table of contents outlining all the documents included and where to find them.
Make Your Next Virtual Audit A Breeze
A virtual audit may require a few extra steps and new technology, but in many ways, it’s not much different from an in-person audit. The goals of the audit are ultimately the same – to assess the conduct of the study, patient safety, and data integrity.
Working with an experienced auditor will make your next virtual audit even easier.
IMARC Research has been conducting remote clinical research audits long before the pandemic. Our team offers an objective, third-party evaluation of your processes and documents to ensure you meet all compliance requirements.
We conduct many different types of audits, including GCP audits, BIMO inspection preparation audits, and vendor audits. If your team is new to virtual audits, we can help you select the right tools are in order before the audit takes place. We will also follow up with your team after the audit to discuss our findings in detail and offer recommendations.
Check out this video to learn more about our remote services.