How an electronic Trial Master File review works

Rachel Silver-Kessler, director of clinical support services, IMARC

You may already know all the documents that your Trial Master File should contain to tell the right story about your study. (Check out our infographic for guidance.) And you can probably guess that a remote audit of your electronic Trial Master File could provide significant savings of time and money compared with hosting an in-person audit. So now you may be asking:

• How does a remote electronic Trial Master File audit actually work?

• What issues do I need to consider for remote audits?

Luckily, the answers are simple.

4 steps to conducting an electronic Trial Master File review

Set the Stage. Share your goals with the auditor so they know if there are any particular areas of concern to address. Should this audit provide a high-level assessment of inspection readiness, or a thorough gap analysis for all sites and all essential documents? The answer will guide the auditor’s process.

Share. Grant the auditor read-only access, and they will be able to assess your eTMF remotely, without needing your team to spend several days with the auditor. If you don’t have this ability, IMARC can provide a file-sharing system so you can simply drag and drop your files in for easy access.

Communicate. The auditor can hold the opening and closing meetings via web conferencing. This gets everyone on the same page before and after the audit efficiently. There should be one person who is the point person for the auditor should questions arise, but by and large, the review will be done independently. After the Trial Master File review is complete, the auditor will provide a report with any findings, opportunities for improvement and recommendations.

Follow Up. Determine which of the auditor’s findings you can resolve. File missing items, close the loops in documentation, develop or improve procedures, and feel confident in your electronic Trial Master File!

How Much Could You Save With an Electronic Trial Master File Review?

As I mentioned, conducting an electronic Trial Master File review can result in significant savings. Considering all the time and costs associated with an in-person Trial Master File review—including airfare, lodging, meals and your staff’s time hosting the auditors—it’s certainly worth considering. An electronic review is ideal for sponsors who are already familiar with the FDA’s auditing process and want an extra set of eyes on their Trial Master File to feel confident that they are adequately prepared for test day.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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