What’s keeping you from going paperless at your study site? Maybe it’s worries about the cost of transitioning to electronic source (eSource) documentation of your study data, or how long it will take. Maybe it’s the learning curve associated with a new system or apprehension about possible regulatory complications. Maybe it’s fear of technology or of change, in general.
On the other hand, said Eric Elander, representing Clinical Research IO in a techXpo session at the ACRP 2019 gathering in Nashville on Sunday (April 14), “we have [numerous] problems with paper, yet we’re still using it.” Among those problems are issues with storage, disaster recovery, access, clarity, environmental conditions, and deviations/missing data. “Paper is not getting any better,” Elander noted.
eSource offers such benefits as edit checks/alerts, missing data flags, to-do lists, and capabilities for remote investigator sign-off and remote quality checks, Elander said, yet most study sites still use paper for source data collection, unless they are conducting oncology trials. What many principal investigators don’t realize is that they can safely use eSource as far as the U.S. Food and Drug Administration is concerned—if the system is deemed compliant with the infamous 21 CFR Part 11 of the Code of Federal Regulations governing use of electronic records and electronic signatures when reporting to the agency.
With the right kind of eSource system, integration is possible with other systems, such as those used for clinical trial management, electronic data capture, electronic medical records, regulatory compliance, and financial records. Sharing their experiences with the techXpo session’s audience of tying eSource to systems for such disparate purposes at their organizations were Kelly Van Schouwen, MS, ACRP-CP, associate director of clinical research for the Spine Institute of Louisiana, Judy Kroulek, RN, BSN, CCRC, lead clinical research coordinator (CRC) with Chattanooga Research & Medicine, PLLC, and Jill Heinz, MHSc, CCRC, owner and site director with Injury Care Research & Family Care Research.
“We were tired of deviations [and] tired of data going missing,” said Van Schouwen of her institute’s switch to eSource. “This really forced compliance [with regulations], not just with the investigators, but with coordinators, too.”
“I didn’t want to have any paper with me from the site when I traveled anywhere, but I still needed to stay up to date with the site,” said Kroulek. “Now I can. [Plus], with our first year [using eSource], we saved nearly $4,000.” The site’s CRCs can now spend more time focusing on patients during their visits, as well, she noted.
Heinz called eSource her last “golden egg” to get for her site after already investing in an electronic regulatory compliance system and a clinical trial management system. “I really thought it was going to be cost prohibitive,” she recalled. However, by hooking into tasks such as patient recruitment and stipends, site finances, visit records, and informed consent, eSource has “reduced the number of systems onsite for coordinators” to deal with, she said. “Now, when we audit, we can audit for the things that matter…[because] we’ve eliminated the little things.”
Author: Gary Cramer
