Regulatory Binders: Your Path to Paperless

Filip Matakovic, MedPoint Digital

Filip Matakovic
VP/GM, Site Services
MedPoint Digital

PAID MESSAGE – Save to PDF, print, copy, file, repeat. Sound familiar? For those handling and managing the regulatory documentation at clinical research sites, it’s a common workflow full of paper and redundancy.

Maintaining a Regulatory Binder is a task that hasn’t changed much over the years. Stacks of documents, protocols, amendments, IRB approvals, correspondences, CVs, logs, forms; all piled in a locked room or a shelf near the regulatory coordinator. If it’s not broke don’t fix it…right? Well maybe we throw that adage out along with the stacks of paper.

That’s where the recent revisions to the International Council for Harmonization’s ICH E6(R2) Guideline for Good Clinical Practice and the U.S. Food and Drug Administration’s 21 CFR Part 11 on Electronic Records; Electronic Signatures – Scope and Application documentation come into the picture. You can find those documents here and here, to catch up on the updates. To sum things up, no more paper binders–mostly thanks to the definition of certified copies and electronic document retention. The requirements for electronic documents and signatures have been defined, opening the door for beginning the path to paperless. Luckily for study sites, there are already several vendors with robust systems to handle the load.

As technology has encompassed the clinical trial space, how we receive and submit documents has drastically changed. E-mails with amendments and downloading documents from sponsor websites is now the new norm. Why not maintain these documents digitally when they already start out that way? Here’s where eReg really shines.

Electronic Regulatory Binder Platforms, like RegDoc eSafe by MedPoint Digital, have begun to be adopted by clinical trial sites at a slow pace. While many sites admit that it’s a great idea and that they’ll get to it eventually, there’s some concern regarding the few hurdles on beginning your Path to Paperless. The cost of continuing to be a research site or organization that is conducting regulatory that is 100% paper-based is high. You’re unknowingly losing time with patients, slowing your study startup, and increasing the risk for error in compliance standards as compared to your peers using a digital system. The first step toward an eReg system is internally deciding to make the move and setting a timeline for change.

The next step in the process is a needs and vendor assessment. With multiple vendors requesting your attention and ultimately vying for your business, how do you choose? Decide what key workflows or features are truly necessary and those that are merely “nice to have.” Find the vendors that address these needs and can prove their solutions. This takes place via a demo; whether it be at a conference, an online meeting room, or a self-paced walkthrough. Take notes and ask as much as you can to get the information you need. We like to offer a trial sandbox account so there is ample time to “kick the tires” on your own time and truly understand the technology investment you’re making.

Another vital topic is the ever-increasing regulatory burden that is the site’s responsibility. The requirements for maintaining documentation seem to only go up for research that is being conducted. Some regulatory bodies require retaining that information for upwards of 25 years. Ask your vendor about storing your study documents “on-system” when study close out occurs. This lessens the need to rely on paper storage archive services and frees up more office space if you store documents onsite.

Quick tips for a successful demo: Ask what new features are in the pipeline and whether these updates are included in the pricing given. How does the vendor plan to train you and your colleagues? Is there technical support? What kind of resources are available? Ask these questions to familiarize yourself with the platform and the team behind the technology. This is an investment into your clinical research site. During this selection process, it’s also critical to begin revising your standard operating procedures to allow for use of digital systems and your site’s approach to certified copies. A good eReg vendor will not only address this, but will have the details ironed out on how to handle them. At MedPoint Digital, we address these concerns, and customers leave feeling much more comfortable with the processes and with the tools necessary to make the transition to paperless.

If you’ve made it this far, one of the biggest hurdles on your Path to Paperless remains. How do you implement and start using the system across your site? There’s no clear-cut answer, as it depends on the specifics at your site. Talk to your vendor and see what insight they have or how other customers have made the switch. Typically, we recommend a jumping off point. After the implementation of the system, any new trials will be conducted using the eReg platform. Yes, unfortunately that means there will be a period that you’ll be utilizing both paper and digital documentation before completing the full transition. Although not completely painless, the benefits of going paperless are worth the effort. This is just one way to adopt electronic resources to make your site more effective and invest in its future.

At MedPoint Digital, we pride ourselves on having delivered top tier services to the pharmaceutical industry for 29 years. Our team is there with you every step of the way along your Path to Paperless, ensuring your success in tackling this new technology. We’re here to help you spend more time with patients, take on more trials with ease, and keep you audit ready at a moment’s notice.