How to Build an FDA Audit Strategy During the COVID-19 Pandemic

    The COVID-19 Pandemic is causing businesses everywhere to have to make changes to the way they operate. While some industries are more impacted than others, everyone is prioritizing one thing right now — staying healthy.

    As a life sciences company, you are at the forefront of innovation in your space.

    You may already have devices or pharmaceuticals that are actively in development. Some of them could even be in the clinical trial phases during this pandemic.

    The U.S. Food and Drug Administration (FDA) issued new guidance on March 18, 2020, to help you navigate COVID-19 concerns while keeping your trial participants safe. They also provide some information on how to help you stay compliant with good clinical practice while minimizing the risk to your trial’s integrity.

    COVID-19: Build an FDA Audit Strategy

    FDA Audits are always a looming concern. You have to carefully document and control every step of your lifecycle from initial conception to final launch and beyond. The guidelines exist for a reason, and these new updates are no different.

    With the right preparation, you can keep your development on track and still pass your audits. Let’s take a look at the most significant sections of the new guidance from the FDA.

    Screening Procedures and Exposure

    You do not have to amend your protocols for COVID-19 screening procedures that are mandated by the healthcare system in which you are conducting your clinical trial. However, if your sponsor anticipates incorporating the screening data as a part of a new research objective, you will have to make the amendment.

    You can make changes to your protocols or investigational plans to address immediate hazards and protect the well-being of your trial participants:

    • Without institutional review board (IRB) approval
    • Before filing an investigational device exemption (IDE)
    • Before submitting an amendment to an investigational new drug (IND) application

    However, you do have to make those reports afterward. An example of such a change would be limiting trial participants’ exposure to COVID-19.

    Clinical Study Reports

    You have several new items that you will need to either include in your clinical study reports or a separate document.

    These include:

    Documentation relating to contingency measures that you implemented to manage study conduct while your study was disrupted due to COVID-19 control measures that you took.

    • A detailed analysis and all correspondence related to the impact of the implemented contingency measures and how they impacted the safety and efficacy results that you reported for the study.
    • A complete list of all study participants that were affected by the COVID-19-related study disruption. You must include the unique subject number identifier by the investigational site as well as a detailed description of how that individual’s participation was altered.

    Additional Recommendations

    The FDA recognizes that some protocol modifications and deviations are going to be unavoidable during the COVID-19 pandemic. They also provided a general list of advice for clinical trial sponsors.

    • Take measures to communicate with participants and keep them aware of any changes to the study or monitoring protocols.
    • If participants missed study visits, could not have efficacy assessment done, or studies were discontinued due to COVID-19, then you need to make sure that you document that information in their case report.
    • Utilize clinical investigators and IRBs or independent ethics committees (IECs) to help you decide if you should consider discontinuing or modifying a study as a result of COVID-19 impacts such as situations where your ability to conduct safety monitoring has been compromised, or you’ve suffered an impact on your investigational product supply chain.
    • If your study cannot be appropriately conducted under existing protocols, then you should consider if you should delay some assessments for ongoing trials, withdraw trial participants, or stop ongoing treatment.
    • Determine if you can utilize alternative methods such as phone calls, virtual visits, or alternative locations to conduct safety assessments.
    • Evaluate if additional safety monitoring is needed for your trial participants that can’t access your investigational product or site.
    • Consult with the FDA to review any divisions about protocol modifications in relation to the collection of efficacy endpoints, the use of assessments conducted virtually, alternative methods to collect research-specific specimens, and any delays in assessments.
    • Before you lock clinical trials into the database, make sure you address any statistical analysis plan and protocol deviations that were related to COVID-19 and how those deviations will be handled for prespecified analyses.

    You Can Lean on Qualio

    We understand that you have to make drastic changes right now in response to this pandemic. We have, and always will be, focused on helping life sciences teams put quality first in their work to bring life-changing products and pharmaceuticals to market.

    We’re here to support you during these trying times with an enterprise-class cloud eQMS platform that helps you optimize and automate critical processes — even when your team is distributed and working remotely during this crisis.

    How can we help you? Contact us today and talk to our experts about your challenges.