Electronic Regulatory Binders, or eReg, is poised to break out in the clinical trial industry. Almost half of all clinical trial sites are either currently utilizing, or are planning on utilizing, software to handle their regulatory documents and duties. Additionally, 70-80% of these sites expect that nearly all trials will be utilizing eReg within the next five years.
Why is eReg Adoption About to Take Off? Three Key Reasons...
Electronic Regulatory Binders eliminate monotonous tasks such as printing, filing and internal routing; thus, most basic eReg software systems have the capability to upload, route, e-sign, download, and print documents. In addition to the built-in alerts that warn your regulatory specialist when a certificate is about to expire, these features save your specialist from being chained to a printer and, in the case of the expiring certificate, panic.
A more sophisticated eReg system has features such as electronic delegation logs and electronic training logs. These systems allow for the creation and delegation of duties to specific users. After the duty log is created, the Principal Investigators can e-sign the duties, either individually or in bulk. Electronic training trackers give your site the power to see which trainings each staff must complete based off of their duties-- an easy way to reduce deviations.
Cost and Time Savings
One of the most obvious benefits of storing your regulatory documents electronically is that you no longer have bulky paper binders. A survey from 164 clinical trial site personal revealed that an average of $13,901 was spent on just the regulatory tasks completed during an average 24-month study. Breaking this number down, the costs came down to 255.5 hours of staff time per study (at $50 an hour) and an estimated of $1,226 in materials costs.
That is 255.5 hours of printing, copying, filing, and tracking down PI signatures that could have been spent on other revenue-generating activities, and $1,226 spent on paper, folders, binders, storage boxes, and off-site document storage.
With an average of 7.4 hours spent just filing paper credentials and CVs, the time costs can be reduced drastically with an eReg system that allows for a one-time upload of these documents, to be shared across all studies.
Access and Security
Because Electronic Regulatory Binders are cloud-based, they can be accessed anywhere and can not be misplaced or destroyed in an accident. Additionally, almost all eReg vendors have regular back-ups, encryption, and other security protocols that make the documents safe and accessible at all times.
If you have decided to take the leap and go fully paperless with regulatory documents at your clinical trial site, it is important to have a solid implementation plan to ensure a smooth roll out.
Start With Compliance...
21 CFR Part 11 and Electronic Regulatory Binders:
Title 21 CFR Part 11 is part of the FDA's Code of Federal Regulations that governs electronic records and electronic signatures. Anyone who chooses to maintain records or submit information electronically is subject to Part 11. eSource and eRegulatory vendors must follow certain procedures to ensure that their system is compliant, which means that electronic records and signatures are accepted as legally binding as their handwritten equivalents -- get familiar with Part 11 here.
If your eReg vendor cannot demonstrate to you that they are Part 11 compliant, you should not be using their system, as it could be a big issue if your site ever received a FDA audit. It is also a huge plus if your eSource vendor is GCP Compliant and HIPAA Compliant.
Bonus if they have evidence of third party validation!
Even if your vendor is Part 11 compliant, there are some steps that must happen on "your end" to ensure full compliance. One of those steps includes system validation, where you must test the system to ensure it functions the way it is supposed to function. A good vendor will provide you with helpful tools and exercises to ensure that everything is squared away.
Having good SOPs relating to your Electronic Regulatory Binders are the key to a smooth rollout. Not only do SOPs inform your day to day workflows, but they are also necessary for showing monitors oversight on how you use the software. SOPs should include the basics-- how the system will be used, who will be using it-- as well as outlines for more unlikely scenarios, such as removing a user and disaster plans.
Once you have completed the compliance and validation for your eReg system, you are ready to fully implement at your clinical trial site.
Implementing Your eReg Binders...
Announcing your eReg Solution
Announce to your team that you are about to implement new Electronic Regulatory Binders. Give them reasons why you have chosen to go this route and emphasize that while initial training is needed, the software will save both time and money in the long term. Assure your team that they will receive proper training and will be fully supported throughout the transition.
This is where the partnership with your eReg vendor comes in. Your eRegulatory vendor wants your clinical trial site to be successful with their tool and should take steps to ensure this success. A good vendor will have a clear training process that fits with you and your team's stated goals and timelines. Training options can include videos, manuals, and private training, as well as self-certification. Be sure to have everyone on board for the training process, you do not want anyone left behind!
Communicate with Your Sponsor
While not necessary, communicating with your sponsor about your new eReg system is never a bad idea. Briefly explain the benefits of this system, as well as the safety features and the steps you have taken to ensure the system is Part 11 compliant. Ask if they have any questions or if they have a process for review and validation. Remember, you are not asking for permission, you are simply giving them a heads up.
Launch your Electronic Regulatory Binders!
Launch your new eReg system! Launch can occur in two different ways: you may want to first pilot on a single trial, then roll out, or, if you feel confident, go all-in on your whole portfolio of studies. It is helpful to schedule regular feedback sessions with users to make sure your team is happy with the workflows and to solve any issues as soon as they happen. Again, this is where your vendor comes in with good customer support!
Anna Krauss is a Project Manager at Clinical Research IO. She has experience in the health field through her work as a Research Assistant with the MaineGeneral Hospital system, Hospital General de Agudos Bernardino Rivadavia in Argentina, and through her experiences working as an EMT.