While electronic document management is becoming more mainstream, it’s still considered uncharted territory for some research sites.
The transition is often approached with trepidation, fear, and questions: Will 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 an eRegulatory system result in sponsor hesitation during site selection?
Over the past several years, Complion has helped many sites move towards a paperless environment. And in our experience, we’ve found sponsor pushback to be a common concern. To that end, Complion offers a few tips to ease the apprehension.
Understand the Regulations and Your Rights
FDA regulations 21 CFR Part 11 permit sites to use e-signatures. Sites have the right to own their processes.
Identify the Benefit to Sponsors and Patients
One of the key aspects to gaining sponsor acceptance is to demonstrate to monitors how they benefit when sites move to an electronic system.
- Time efficiency. Monitors can spend fewer days onsite. For example, a three-day visit can easily drop down to a two-day visit. Source documents can be verified during the onsite visit or even remotely. Additionally, regulatory information can be handled remotely as well.
- More transparency and faster response times from sites. 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 or four binders worth of stuff, we had all the correspondence for the entire study from the time it began to the time it closed saved into a single 150 megabyte file that could be placed on an FTP site and sent to the monitor,” Surasky notes.
- Streamlined study start-up and reviews, better data quality, improved oversight, and inspection readiness. Essentially, the system is audit ready. There isn’t a need to search 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 — have it instantly, and it’s controlled by the site.
- Shortened cycle time. This is perhaps the greatest benefit; one 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 in an SOP. If a sponsor, monitor, or auditor were to inquire about your procedures, a well-developed SOP eases any concerns.
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. This will not only help facilitate a consistent approach to implementing technology, it will also 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 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 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.
- 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, you may want to carry them over into your contract, particularly concerning electronic document management. Sponsors appreciate when sites are transparent from the onset about being paperless as it demonstrates the research site is well organized and prepared. This transparency also extends them the courtesy of allowing the sponsor to adjust their processes as well.
Another recommendation is to tailor 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 eRegulatory, it’s important to select a partner that will collaborate with you to provide the tools and resources needed to tackle sponsor concerns if they arise.
When Surasky experienced uneasiness from his organization’s sponsor during the transition, Complion was brought into the discussion:
“Two weeks later, the sponsor rep was actually back at our site. He indicated after talking with the staff at Complion, they [sponsor] had no problems with our eReg system, and would go ahead and use our system for all the signatures.”
Complion has the tools and the staff to help ease the transition. Are you ready to adopt an eReg system? Schedule a demo.