It has been more than 20 years since the FDA established that electronic documents and signatures were trustworthy and acceptable for use in clinical research (so long as they meet 21 CFR Part 11 requirements). In that time, many research organizations have taken the opportunity to free themselves of the struggle to manage mountains of paper and chase down doctors for signatures. But many have yet to make the transition.
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As a research coordinator or administrator, being buried under a mountain of paper files is something that doesn’t have to happen often before the light bulb in your head suddenly glows with the realization that there must be a better way.
Light bulbs are clicking on in similar fashion across the industry, and their accumulated illumination is shining on eRegulatory systems. The rate at which organizations are adopting eRegulatory systems makes it quite clear that it’s only a matter of time before the eRegulatory bandwagon shows up in your site’s parking lot.
New Case Study Offers Insight into an FDA Inspection from a Research Site using eRegulatory
If you find yourself standing on a railroad track, you can expect that at some point you’ll hear the distant whistle and rumble of an oncoming train. At that moment the smart decision is to step off the track in preparation of the train’s arrival.
For clinical research sites, FDA inspections are a bit like an oncoming train. They don’t whistle or rumble, but you know they are coming. You just don’t know exactly when. The difference between getting rolled over by the inspection and surviving unscathed comes down to preparation. What are you doing to step off the tracks?
From Burden to Opportunity
Remote monitoring technology initiated by sponsors often inflicts additional burden on sites, requiring them to not only print and file their regulatory documents, but scan and upload them to multiple sponsor portals, too. However, sites are beginning to identify more efficient ways to enable remote monitoring. Empowered sites are taking control and initiating technology from their side to enhance collaboration with sponsors and streamline processes, ultimately lifting their day-to-day burden.
Scenes of someone being relentlessly pursued, perhaps by zombies, vampires, flying sharks, or some combination of any or all of the above, are common on TV during Halloween season. And that’s ok. But somewhat similar scenes are also playing out in the halls of research facilities as research nurses or regulatory coordinators attempt to chase down busy Primary Investigators (PIs) whose signatures are needed on essential documents. Staff members set up ambushes, pen and documents in hand, waiting for unsuspecting PIs. Or they set out the documents where they hope the PIs will see and sign them, which only increases the chances that the documents will disappear.
Flooding in Houston. Wildfires in Sonoma. Utter devastation in San Juan. Natural disaster has dominated recent headlines, providing a sobering reminder of just how susceptible we are to the power of nature. Watching the news coverage of people struggling to rebuild lives, homes, and businesses, I find myself wondering if it is even possible to be prepared for such incredible destruction. There are limitations to how much you can protect yourself and your property, and given the level of destructive force on display in recent disasters, it seems the only truly viable precaution is to be somewhere else.
It’s an increasingly common occurrence at clinical research sites, that moment of realization that the organization is choking on paper. A blizzard of documents and a mountain of bulging folders crushing efficiency and slowing processes to the point that a fleeting thought about a splash of lighter fluid and a well-placed match might pass through the mind of a harried site executive.Cooler heads prevail, of course, and far less incendiary solutions are readily available.
Complion has been such a solution for a great many research sites, including South Texas Cardiovascular Consultants (STCC), a research hospital that serves patients in four locations throughout Texas.
How the right partner can smooth the path to a fully compliant regulatory and document management system
Efforts to transition to a streamlined paperless operation are unquestionably worthwhile. But the characteristic increases in efficiency are of little value if the transformed organization falls short of 21 CFR Part 11 compliance. That is why it is critically important that every step on the path to the paperless transformation is guided by professionals who are deeply, intimately familiar with the requirements for compliance.