Remote auditing isn’t new, but it’s becoming more popular as clinical research teams become increasingly distributed.
Remote audits have also become more relevant recently as clinical trial operations transitioned from on-site to remote during the coronavirus pandemic.
If you’ve never considered remote auditing before, you might be wondering how it can benefit your trial and whether it’s the right approach for you.
Here’s a closer look at the benefits of remote auditing, the types of remote audits and what to consider before you conduct a remote audit.
What is Remote Auditing?
Auditing offers clinical researchers the opportunity for an objective review of their trial documents before the FDA sees them.
Remote auditing offers the same oversight as traditional auditing, using direct access to electronic medical records, electronic trial master file documents or a secure file-sharing platform. Any audit should start with an understanding of the goals so the auditor knows where to focus his or her attention. After discussing these goals over a conference call, researchers grant read-only access to the auditor.
Once the auditor has finished reviewing all pertinent documents, he or she will schedule a follow-up call to discuss the findings.
4 Big Benefits of Remote Auditing
It’s More Convenient
A traditional audit may involve several days of intensive, on-site review of your clinical trial documents. During this time, your in-house team is often working closely with your auditing team. This takes time away from other pressing clinical trial activities. With remote auditing, you simply grant auditors access to your documents, agree on a timeline and allow them to do the work at their convenience.
It’s More Cost-Effective
On-site audits can incur substantial travel costs. There may be two or three auditors present for several days, each of whom must purchase a plane ticket, reserve a hotel room and pay for meals. Those costs are typically passed on to you. Eliminating these additional costs can reduce the cost of an audit by as much as half!
It Helps Ensure Compliance
Auditors who are well-trained in FDA regulations and BIMO inspections understand what inspectors will look for and structure their process accordingly. Their goal is to identify any protocol deviations, data discrepancies or potential violations that could result in FDA warning letters. This helps you approach your FDA inspection with confidence so you can earn approval and bring your device to market faster.
It Helps You Identify Additional Training Opportunities
In addition to ensuring compliance, any effective auditing process should identify opportunities for improvement. It may not be an issue that warrants a violation, but it could be an indication your team needs to improve communication, update your standard operating procedures or invest in additional training.
Types of Remote Auditing
Site GCP Audits
These audits are designed to assess how well your sites are following the fundamentals of Good Clinical Practice (GCP.) A site GCP audit will identify, analyze and strengthen weaknesses in compliance areas, including:
- IRB requirements
- Sponsor requirements
- Internal site SOPs
These audits are ideal for newer sites, sites that have had recent staff turnover or even more experienced teams that have not reviewed their protocol or SOPs in the past year or two.
Vendor Qualification Audits
Vendor qualification audits evaluate the capabilities and performance of third-party vendors. They evaluate a variety of areas, including:
- The overall organization
- Qualifications and training of the vendor’s personnel
- The vendor’s SOPs
- How the vendor maintains records
- The vendor’s facilities and equipment
These audits are designed to prepare your team for a regulatory inspection, such as an FDA BIMO inspection. They review key items, including:
- Your organization and personnel
- Monitoring activity
- Quality assurance
- AE reporting
- Data collection and handling
- Electronic records
- Product accountability
Trial Master File Audits
Your Trial Master File (TMF) tells the full story of your study. You want to ensure it’s accurate and complete before you submit it to the FDA. An electronic Trial Master File audit reviews all your documentation, making note of any errors, missing documents or discrepancies.
Is Your Study a Good Fit for Remote Auditing?
Almost every study can benefit from additional third-party oversight. However, before you move forward with remote auditing, you’ll want to consider a few things:
- Have we established specific goals for our audit?
- Are our documents well-organized?
- Do they meet the ALCOA-C guidelines for documentation?
- How easy is it to grant remote access to our study documents?
- Have we conducted clinical trial audits before?
While remote auditing may not be the best fit if this is your first clinical trial and you want more hands-on guidance, it’s ideal for more experienced research teams.
IMARC can assist with both on-site and remote auditing, depending on your team’s needs. Our team has more than 20 years of auditing experience, and we make the process easy. If your team is unable to provide access to electronic medical records, we can use a secure, compliant file-sharing platform to review your trial documents.
Once we’ve conducted our audit, we’ll take the time to discuss our findings and provide ongoing support as needed, whether it’s remote research coordination, monitoring or additional training.
Contact us today to learn more about how your trial can benefit from remote auditing.