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.
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.
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.
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.
Complion is honored to have recently published an article in Clinical Researcher, the peer-reviewed flagship publication of the Association of Clinical Research Professionals (ACRP).
Clinical Researcher is published six times a year and features articles on the latest developments across the spectrum of specialty areas in the clinical research enterprise, as well as highlighting valuable insights and resources from columnists, internal and external news sources, and the Association’s partner organizations.
Written by Complion VP of Professional Services Cristina Ferrazzano Yaussy and Oklahoma Heart Hospital Senior Director James Wetzel, Ensuring Compliance with Part 11: A Site's Perspective focuses on best practices for maintaining maximum efficiency while meeting the challenges of Part 11 compliance.