Understanding a Site’s Responsibilities for Essential Documents in Electronic Systems

Stuart Cotter, VP, Product Strategy, Advarra

As the saying goes, “With great power comes great responsibility,” and with so many clinical study site leaders now taking technological powers into their hands that were traditionally held by sponsors, some of them and their staff may be surprised to find the awesome responsibilities that come packaged with the deal.

For example, how many site personnel finding themselves in charge of a shiny new eRegulatory system for the first time realize that, along with keeping track of who has the keys (or passwords, in this case), the U.S. Food and Drug Administration (FDA) now expects them to comply with the expectations laid out in the owner’s manual for the scope and applications of electronic records and electronic signatures in those systems—otherwise known as 21 CFR Part 11 in the Code of Federal Regulations?

“Primarily, study management technology for handling essential documents that is provided by a sponsor for a site will be taken care of by the sponsor, but increasingly, sites are buying their own technology for eRegulatory tasks and entire eRegulatory binder systems,” says Stuart Cotter, Vice President for Product Strategy at Advarra. “Also, some sites have eSource software that they’ve purchased, and now it’s the site’s responsibility to make sure that these, and any other systems, storing records for FDA comply with 21 CFR Part 11.”

At the upcoming ACRP 2024 conference, Cotter will lay out the foundational information that is important for sites to know when dealing with the technologies of the e-universe that are of greatest interest to the FDA when its inspectors come knocking, because one of the things they don’t want to hear in response to a query about the site’s study management practices is “We thought the sponsor took care of that.”

“At a basic level, it isn’t hard to be in compliance to protect sites from audit risks when inspectors show up and you have your study source and regulatory documents in an electronic system,” Cotter notes. “Most sites will already have experience with FDA inspectors coming to perform inspections on one or more studies, and one of the first questions they will ask is ‘How do you store your records?’ And when you respond ‘With eSource’ or ‘In an eRegulatory binder system,’ the inspector is more than likely to ask about how you comply with the regulations for those systems.”

Strategies for Ensuring Part 11 Compliance for “eSystems” at Research Sites

Join Staurt at ACRP 2024 [May 3 – 6; Anaheim, CA], as he focuses on how sites need to understand the requirements and develop strategies for compliance, especially as it relates to CFR 21 Part 11 in the Code of Federal Regulations. View complete schedule.

Most of the reputable technology vendors providing software for such systems to sites will develop it with 21 CFR Part 11 compliance in mind, Cotter says, but site staff still need to validate and test the software and keep records on doing so at the site level to show the FDA. Any system found not in compliance will likely earn the site an FDA Form 483 (Inspection Observations) from the inspector, rejecting the validity of the records from that system, “Which would be a problem not only for the site, but for the sponsor, and would impact the integrity of the research and the validity of the data and the whole study,” Cotter advises.

Further, if the site doesn’t react appropriately to the 483, a Warning Letter could follow and failure to take that seriously could even lead to disbarment of the site’s principal investigator. “But more likely, when the inspector points out that a system is not compliant with 21 CFR Part 11, the site will fix it and studies can go on as intended,” Cotter says. “To keep everyone happy and on the same page, sites need to understand how this regulation applies to the technologies they are using so that they can take some relatively easy steps to assure that they are in compliance, so in my ACRP 2024 session, we’ll discuss those steps.”

Author: Gary Cramer