The paperless trend is sailing across the industry and continues to gain momentum. While electronic document management is becoming more mainstream in research, it is still considered uncharted territory for some sites and a voyage for others.
Some sites approach this change with trepidation, fear, and questions. Will their sponsors accept documents signed electronically, or will they balk at the mere suggestion? Will monitors resist reviewing site documents electronically? Or, worst of all, will adopting electronic document management result in sponsor hesitation during site selection?
Change isn’t easy. Inertia tends to keep us moving forward on a single track, and any deviations from that familiar path will raise questions and uncertainty. Many sites go where the current takes them.
I have observed sites change course and successfully lead their sites to a more efficient future. They envision smoother sailing and have charted a new course.
Elizabeth Couch, Manager of Research Regulatory Operations at Norton Healthcare has described such sites as “captains of their own ships.” They see the winds of change as an opportunity and harness it to their advantage. Sponsor push-back is a common concerns for sites looking to go paperless. But from my experience these fears If you’re afraid of sponsor resistance, simply view it as merely a bit of wind and just adjust your sails!
Jill Heinz, Site Owner and Director at Treasure Valley Clinical Research, is a great example of an site that overcame her reservations and led her organization to change. Here experience is documented in the webinar, eRegulatory Experiences from a Site Without Binders. Early in the transformation, Jill was stuck in contemplation. “What are the study sponsors going to think? That’s who pays me. That’s my client. I need to make sure they stay happy.” While Federal regulations make the regulatory binders the site’s responsibility, Jill was afraid that the study sponsors would stop placing studies with her.
But those fears never materialized.
Over the past few years, I have observed and helped many sites move towards a paperless environment. In recognition of this issue that some sites may be concerned of sponsor push-back, I’ve assembled some helpful tips identified while working with industry leaders who know their regulations and run a tight ship.
Understand the Regulations and Your Rights
Dustin Caldwell at OptiMed Research had similar concerns in the beginning of the process. In the clip below from the webcast More eRegulatory Experiences–Embracing a Paperless Process for Your Site, Dustin explains how he overcame this concern.
Dustin states, “the first time that [Lisa] contacted our site about this, I said no because I was afraid that the CRAs and the sponsors wouldn’t accept this. Dustin continues by explaining, “At the same time, I’d actually been introduced to another group that was doing work primarily for sponsors, and CROs and they were trying to get CROs to adopt an [eRegulatory] system that they would force the sites to use. I saw that it was happening in places in the industry; I just hadn’t seen it happening this way.” Dustin explained, “Everything really fell into place really nicely once we realized that this was something that the industry would allow us to do.”
At the heart of this issue is often a misunderstanding of the regulations. At the recent ExL Clinical Trial and Billing Conference, I attended a presentation pertaining to sites implementing a paperless process. I overheard a site representative whisper, “the sponsor will not accept documents with e-signatures”. Counter to her statement, FDA regulations 21CFR Part 11 permit sites to use e-signatures. Sites have the right to own their processes. But, if sites don’t know the regulations, they may be naive about their rights. And if they don’t know their rights, they can’t take control of their processes!
During that same presentation Candida Barlow, MSN, RN, Director of Clinical Research at St. John Clinical Research Institute, proudly exclaimed to her colleagues “My House, my rules”. She knows the regulations, and she knows them well.
Identify the Benefit to Sponsors and Patients
One of the key aspects to gaining sponsor acceptance is to demonstrate to monitors how the system benefit when a sites moves to an electronic system. Jill Heinz found that monitors quickly embraced the new system because it’s time efficient and allows them to spend fewer days onsite. “Instead of having a three-day visit, they can drop it down maybe to a two-day visit,” Jill explains, verifying source documents during the onsite visit, and then handling the regulatory information from home the following day. “They also can go in without even talking to me. They don’t have to talk to our coordinator who’s working on the study. They don’t have to call me for a document.”
Monitors also receive the added benefit of more transparency and faster response times from sites. In the webcast, Neal Surasky of Chesapeake Research Group (CRG) describes a situation in which a monitor for a study that had just closed asked for all of the correspondence for that trial so she could upload it to her sponsor’s master file. “In about five minutes, rather than having three, four binders worth of stuff, all the correspondence for the entire study from the time it began to the time it closed was saved in a single 150 megabyte file that I could just put up on an FTP site and send to her. It was amazing.”
OptiMed had run into similar problems with correspondence, particularly in ensuring that monitors had access. “We just went through an audit a couple months ago,” Dustin explains, “and correspondence was one of the biggest things that she looked at. She said, ‘I just want to see the narrative, I want to understand the narrative.’ To be able to effectively transport that narrative and put it directly into the system without having to compile and reconfigure a conversation after the fact is extremely helpful.”
Other advantages to underscore while approaching your sponsor include streamlined study start-up and reviews, better data quality, improved oversight, and inspection readiness. Essentially, the system is audit-ready. No need to hunt through folders or try to reconcile documents, because there is one source of truth. Those who need access -- a PI, monitor, sponsor, auditor, or the FDA -- can have it instantly, and it is controlled by the site. Overall, the greatest benefit may be a shortened cycle time, which ultimately benefits the patient.
Demonstrate Compliance by Establishing Policies or SOPs
When transitioning to a paperless process, sites should determine in advance which records they plan to maintain in electronic format and document this decision in an SOP. Should a sponsor, monitor, or auditor inquire about your procedures, a well-developed SOP will ease their concerns. This is like charting your course and helps to establish the expectation of where you want to go.
SOPs demonstrate a commitment to quality and reinforce the operational practices that a site upholds. They also serve as a resource for training staff so that research teams understand their roles in following procedures and maintaining compliance.
As a best practice, sites should maintain a portfolio of SOPs (See Figure 1). This will help facilitate a consistent approach to implementing technology and safeguard against any potential oversights of the critical components of Part 11.
- SOP Development and Maintenance - Outlines the process by which all other SOPs are developed, approved, and maintained.
- Vendor Selection/Audit - Outlines the procedures of performing vendor audit to ensure software providers are selected based on their capability to provide quality software and documentation for system validation.
- Records Management - Outlines who will manage, and the process for managing, documents including Certified Copies, Retention, and Accessibility.
- Software Implementation and Maintenance - Outlines initial Validation, User Acceptance Testing (UAT), ongoing Maintenance and Change Control procedures.
- Electronic Signature Policy - Attests that users understand that their electronic signature holds them accountable. Note, a letter of Non-Repudiation Agreement for digital signatures must be submitted to the FDA prior to change. (Citation: FDA - Letters of Non-Repudiation Agreement)
- Training - Ensure users have adequate training and agree to terms of using the system.
Establish Your Expectations at the Onset of Your Voyage
After creating and documenting your policies it may make sense to carry them over into your contract, particularly concerning electronic document management. During the ExL Investigator Site File (ISF) conference I attended earlier this year, sponsors indicated they appreciate when sites are transparent about being paperless from the very beginning as this proves the site to be well organized and prepared. This transparency also extends them the courtesy of allowing the sponsor to adjust their processes as well.
In a recent webinar, Steps to Paperless Clinical Trials, Betsy Fallen, former Director of Site Ready and Clinical Operations for Merck, suggested tailoring your site profile to identify that your site has gone digital. This indicates you are a progressive site on the cutting edge of technology.
Find the Right Partner
When contemplating a move towards a paperless process, it’s important to choose a partner that will stand in your corner and provide the tools and resources needed to tackle sponsor concerns, should any arise.
When Neal Surasky experienced concerns from their sponsor during the transition, I was brought into the discussion and was able to ease their concerns. Two weeks later, “the rep was actually back at our site, and she said ‘oh, by the way, I spoke to our people and after talking with Lisa, we have no problems with your system, we’ll go ahead and use your system for all the signatures.” The sponsor came in, along with a monitor who had been active on the site and had expressed appreciation for the way CRG made use of Complion.
“It was really comforting to know that we didn’t have to fight that battle alone. Complion has all sorts of documents, all sorts of validation tools, and their staff is more than willing to talk with whomever we feel they should talk with in order to facilitate the transition to their system.” Since then, Neal reports that CRG has had no other issues with any other sponsors.
If hesitation about sponsor acceptance is holding you back from moving forward with going paperless at your site, I hope you’ll find this information enlightening and empowering, and find the encouragement to at least explore further. Perhaps someday you will embark on your own paperless voyage!
If you have conquered those fears and made your way to your paperless destination, share your experience and insight by posting a comment. I want to hear your story.