Research protocol complexity is increasing and trial volumes are growing. The result – sites are struggling to take on more with the same team. Physicians and research teams are overwhelmed with cumbersome documentation and oversight requirements spread out across multiple locations. Workload imbalance and audit risk anxiety has led to turnover – exacerbating the problem.
Is now really the time to rock the boat?
The answer – YES. Now is the perfect time. With the new eCTD mandates expected in May 2017, which will require sponsors to submit their TMFs in 100% electronic format, much of the clinical research industry is already undergoing the transition to digital recordkeeping. While this may seem daunting and scary at first, electronic document management offers many benefits that paper binders and institutional share drives cannot. These benefits reduce compliance risks as well as the accompanying audit anxiety. And we can tell you from experience, PIs can make the transition, too.
Here’s how you can sidestep some risks as you transition your PI:
Risk #1: “I need your signature – now!”
PI oversight requires physicians to review and sign documents – a lot of them. Traditional approaches – like research coordinators toting around sensitive documents in search of elusive signatures – can lead to backlogs caused by scattered research center locations, busy clinic schedules, and physician travel. When physicians have the time to sit down, thoroughly review and sign the documents, the timelines typically do not reflect the speed of “PI oversight” desired to ensure that patient safety and protocol compliance are maintained.
With eSignatures, physicians can review and sign Delegated Task Lists, Training Logs, and Protocol Amendments – from anywhere in the world. Instant access, no backlog, and organized signature requests that let PIs focus and move on to other things.
Risk #2: “Patient 101 had an Adverse Event (AE). I need to know if it is significant and related to research now!”
Clinical research is conducted to determine the safety and efficacy of new therapies prior to their approval for use in general patient populations. The accuracy of these studies relies heavily on identifying complications and risks quickly. Waiting to review a stack of study patient medical records and Adverse Event documents to determine significance is rarely in the best interest of the patient or the investigational therapy. With all of these responsibilities competing for time and attention, simply tracking Adverse Events may be a challenging task for a team.
Solution: Remote Adverse Event (AE) Documentation Review
Electronic systems allow a research coordinator to print EHR records directly to their eRegulatory Binder. A simple task creation to evaluate an AE will initiate an efficient remote review workflow for the physician, reducing delays and reporting time. The win – therapy complications are discovered more quickly and patient safety improves. PIs get direct access to the documents they need to review.
Risk #3: “We want to get the cutting edge research. How do we prove our research center is the best of the best?”
Participating in the novel, coveted studies requires a history of excellence. As sponsors select sites, the list is often narrowed down by site success indicated by key timeline metrics. Traditional methods of spreadsheet tracking and sponsor newsletter updates reflect high level views of success but lack the ability to identify critical bottlenecks.
Solution: Electronic Dashboards
Real-time dashboards allow teams to select areas of interest to review timelines, identify bottlenecks, and implement solutions to eliminate them. The ability to run historical analysis reports showcases site improvements over time. This central oversight also materially reduces surprises or hidden risks in the event of an FDA audit, and can help rebounding research teams show responsiveness to letters issued in the past.
About Florence eBinder Suite™:
Florence eBinder Suite™ was developed with the busy physician and research team in mind. Our partners say that eBinders are simple, improve compliance, and allow their teams to avoid the compliance errors that lead to FDA action. Interested in improving your compliance, reducing audit risks, and ensuring your site’s success year after year? Contact our team for a demo today at firstname.lastname@example.org.
Emory, Medtronic, BS in Biomedical Engineering from Georgia Institute of Technology
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