Electronic signatures can reduce costs, increase operational efficiencies and strengthen research sites’ security. Yet as of 2016, more than two-thirds of sites haven’t adopted this technology. Why?
Old habits can be hard to break, but these sites may also worry about eSignatures affecting their staff and processes—and their relationships with sponsors or CROs as a result. Fortunately, you can ensure a positive transition for all parties, and reap the benefits of eSignatures, by understanding and enacting some basic best practices.
Handle Regulatory Needs
FDA regulation 21 CFR Part 11 outlines the requirements for electronic records and electronic signatures. In short, these guidelines seek to ensure electronic data is secure, uncorrupted and can have any changes traced. eSignatures must be as trustworthy as those on paper, and your site must confirm this.
First, file your letter of non-repudiation with the FDA. This indicates that your site treats eSignatures as legally binding and equivalent to handwritten ones. Second, adjust your standard recordkeeping and document procedures. These will likely be tweaks, not overhauls. Finalizing these before training staff can help you frame that process and anticipate potential questions.
Aid Staff Adoption
Your staff will use eSignatures most frequently, so they must be on board with this technology. It takes time to create new habits, but you can hasten the process by setting your staff up for success. That means providing hands-on training, ongoing support, and perhaps most importantly, demonstrating the personal benefits of this switch.
For staff, those perks may include spending less time managing paper, gaining visibility over outstanding activities without maintaining separate logs, and easily filing, archiving and retrieving signed documents. Of course, for all that to happen, your eSignature process must be simple and efficient. Having staff members help design this can ensure it meets their specific needs—like working on all mobile devices, for example.
Ensure Sponsor/CRO Acceptance
Sponsors or CROs that your site works with are the other key stakeholders for eSignature adoption. For these individuals, proactive communication can ease the transition. For instance, set expectations at the beginning of the relationship by including language about eSignatures in your contracts and SOPs. Giving them a copy of your letter of non-repudiation can provide necessary context as well.
Remind monitors before site visits of your use of eSignatures, too. Those monitors, or the organizations they work for, may wonder about your compliance with Part 11. Be ready to demonstrate the necessary processes for them—or be sure to select an eSignature vendor that will provide an additional layer of support.