The phrase “Audit Ready” is casually tossed around as a standard practice for both sites and sponsors. When I worked as a research coordinator I went to great lengths to make sure my binders were audit ready, particularly for one study that was deemed a high risk for inspection due to the novel nature of the product and the upcoming PMA (PreMarket Approval) submission. Over a period of eight months the sponsor’s audit team, monitors, and field support teams all inspected my records.
Everything felt great – right up until the point the phone rang and it was the FDA investigator. Despite our ongoing efforts to ensure compliance, panic still ensued. Our team wondered, “What is missing that we don’t know is missing.”
Why the angst?
With sites all over the world and limited monitor resources, at inspection time the sponsor is left feeling anxious about binders that they themselves haven’t been able to inspect in several months – binders that hold critical pieces of evidence for their submission.
Site binders tell a story about the quality of the research conducted. Gaps, inconsistencies, violations, or any chaos in your binders can result in the FDA inspector reporting negatively on the value of your site’s data, and your diligence lends credibility to the sponsor’s claims in their PMA that their product is safe and effective. This report can ultimately impact both the success of the sponsor’s product submission as well as your center’s ability to conduct future research. A lot is on the line.
Because everything was on paper at our site, the only way for the sponsor to know if a critical document had been removed recently was for someone on their team to physically come to the site to inspect the binders again – a frustrating and time-consuming task given all of the prep done to date. They requested to send a team immediately to double, triple, quadruple check our binders and make sure all required regulatory items were ready for inspection.
Many sites do not permit these last-minute sponsor checks, as their coordinators have reported that it increases their inspection anxiety. Others welcome the last-minute help. Regardless, these conversations and decisions bear the risk of placing stress on the valuable sponsor-site relationship.
There should be a better way.
From this experience, we were left with three major questions:
- Are in-person checks really the only option to ensure your team’s records are where they should be every day – including on audit day?
- How can sites always be confident in saying, “We are Audit Ready now”?
- How can sponsors feel confident in knowing that their sites are ready without placing stress on their relationships?
As the result of interviewing over 200 sites during product development, we’ve built our eBinder Suite with checks that aim to answer these three questions and turn this preemptive audit anxiety into Audit Ready.
- Secure document tracking: Through audit trails, alerts, and secure viewing permissions, the team is notified when changes are made to documents. No more surprise missing documents or miscommunication regarding who needs to do what.
- eTMF access: With shared eTMF folder views, sponsors need not wait for months or make a last-minute visit to understand the status of their studies.
- Quick-look Global View: A quick glance at the binder’s Global View highlights any documents that are due, expiring, or already expired.
- Remote monitoring access: Set a “View Only” option so that from anywhere in the world, the sponsor’s audit team can confirm that all documents are where they need to be – no travel required!
The Florence eBinder Suite was designed by security experts and research coordinators to eliminate redundant tasks, improve compliance, and allow concerns to be quickly identified and resolved. Sites and sponsors have immediate insight into the stories their binders tell from the comfort of their own desk. This ensures compliance without negative impacts to their relationships. The suite is HIPAA and 21 CFR 11 compliant and ready to support your team’s efforts towards being Audit Ready now. Contact us at firstname.lastname@example.org or request more information to learn more.
Emory, Medtronic, BS in Biomedical Engineering from Georgia Institute of Technology
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