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.
In life and in business, so many tough decisions would be so much easier to make if you only had the ability to see into the future. But in the real world, the best you can do is to draw on the experience of others who have faced similar critical decisions, learned what works and what doesn’t, and applied those lessons to shape your decision.
For most sites the transition to an eRegulatory system is not a matter of if, but when. Fortunately, you have a unique opportunity to draw on the experience of panel of professionals who have completed that transformation at the 2017 Global Site Solutions Summit, taking place October 6-8, 2017 in Boca Raton, FL.
The following was provided by the audience question and answer session that was part of the Complion webinar, “Best Practices for Participant Safety: Assessment, Documentation & Reporting of Adverse Events,” featuring Elizabeth Ness, MS, BSN, RN at the Center for Cancer Research, NCI, Ilana Logvinov, RN, MSN, CCRP at Mayo Clinic College of Medicine, and Yolanda McKinney, RN, BSN, CCRC at the Center for Cancer Research, NCI.
The following is based on the Question and Answer portion of “Document Management Success: A Guide to Part 11 System Validation,” a Complion webcast featuring Michelle Grienauer, JD, MPH, Senior Regulatory Attorney at Kinetiq, and Cristina Ferrazzano Yaussy, MPH, CCRP, VP of Professional Services, Complion, Inc. The webinar explored what clinical research sites should know about validating eRegulatory and document management systems.
366 individuals from the clinical research industry attended: 31% from an Academic Medical Center, 23% from a Hospital or Health System, 12% from a Dedicated Research Site, 11% from a Cancer Center, 7% from a Physician Practice, and 5% from a Sponsor or CRO. Prior to the webinar, the audience was polled to collect feedback about the current state of document management and validation.
Complion, the industry-leading regulatory and document management platform for clinical research sites, will be speaking and exhibiting at the 9th Annual AACI Clinical Research Initiative Meeting from July 12-13, 2017.
Complion Founder and CEO, Rick Arlow, will be conducting a vendor presentation on Thursday, July 13, entitled, Going Paperless: Managing Regulatory & Clinical Trial Documents in Complion. Mr. Arlow will discuss best practices for managing regulatory and clinical trial documentation in cancer centers. In particular, he will explore document and information management from a research enterprise perspective, defining how systems and teams can (and should) function together to centralize information and drive performance.
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.