This blog post was provided to PFS Clinical by Complion, Inc.
In an effort to reduce the time and expense associated with paper-based systems, more sites and institutions are looking to implement paperless technologies to manage regulatory and trial documentation.
Taking those first steps toward implementing an electronic system may feel like stepping into the dark unknown, but it doesn’t have to. Others have made that transition, and their experiences can illuminate your path to the same destination. Follow these best practices to help ensure a successful transition from paper-based systems to the speed and efficiency of a document management system.
1. Set Goals and Expectations
Many sites are eager to jump in, often with little effort expended on setting goals and expectations. Implementing a new document management or regulatory solution requires changes in familiar processes and procedures. When setting expectations for any type of roll out, envision what a smooth roll-out looks like and identify what factors are critical for success. Maybe implementing electronic signatures is a top priority, or perhaps reducing onsite binders to free up office space is the main goal. Identify how your current processes will change and build in time to evaluate your progress as you go.
2. Get Staff, Stakeholder and Physician Buy-In
Perhaps the single most critical success factor is getting staff buy-in. Most people don’t like change. In an industry where a lot of people have years of experience with established procedures, it can be especially difficult to see the potential of how going paperless can improve efficiency. Allowing staff to participate in the process will lead to a better understanding and ownership of the process and transition. All of the internal stakeholders should understand the purpose behind the transition and the benefit it brings to the site. Securing the commitment of internal staff and external stakeholders will help facilitate ownership and drive the transition forward.
There is significant value to be gained from physician buy-in as well. In a recent case study, Neal Surasky, Data Manager and Quality Assurance Coordinator of Chesapeake Research Group, indicated that a key factor to going paperless was getting physicians to electronically sign and review documents. Given varying degrees of technical savvy among PIs, “we were concerned about how that would work and about integrating new technology into their everyday activities,” Neal explains. Some of those concerns came to bear at the outset. “Early on we had to handhold one of our PIs through it.” But the initial discomfort quickly gave way to acceptance and appreciation. The PIs and others have embraced the new system. “The challenges we thought we might encounter never panned out,” says Neal.
Effective change management can help to smooth the transition, especially for veteran employees who have demonstrated expertise in processes that will be revised under the new system.
3. Commit for All (New) Trials
The smooth transition to a new electronic solution can be greatly aided by limiting the implementation to new trials only, rather than converting or adapting existing studies. Based on our experience this is the strategy applied by most sites.
This strategy can also smooth the process of bringing sponsors and monitors on board, perhaps through a one-page statement of operations that states, going forward, this is way you intend to do business. You can further explain that in meeting your GCP and FDA requirements to maintain your own processes, your stakeholders will have access to tools and features -- such as remote access -- that will save them time and money.
4. Don’t keep Paper Backups
As a research site, it is your responsibility to maintain compliance with GCP and FDA Part 11 requirements. You must place your complete trust in whatever system or process you have put in place to achieve that compliance, even if that means you have eliminated a paper backup. Some sites want to keep a paper backup when moving to an electronic regulatory solution. But this will end up creating a lot of additional work and other issues.
In another case study, Jill Heinz, Site Manager of Treasure Valley Clinical Research, admits that early attempts at easing study sponsor’s concerns by using a mix of paper binders and digital binders was a mistake. “Please do not do that,” Jill warns. “That’s the worst-case scenario because now you don’t know what went where.” Trust the system, she advises. “We didn’t initially and it caused a ton more work for my staff.” Rest assured that an electronic system will allow you to easily convert digital files to PDF when needed.
Transitioning to an electronic system does not have to be a massive undertaking and it doesn’t have to happen overnight. Focus on new trials, and allow the value to emerge over time as you move along the trajectory of the regulatory maturity model.
5. Define Standardized Templates and Nomenclature
Creating standardized files, binder templates and document naming conventions will ensure uniformity across your organization as it applies to processes and the use of materials. Centralization is part of that effort, including identifying the documents and other resources that can be shared to eliminate the redundancy and duplication that can threaten the integrity of the regulatory information. Similarly, take steps to identify and define types of workflows and the staff members involved in each.
6. Commit to Part 11 Compliance
As more sites look to implement technology to go paperless, experience with ensuring compliance with 21 CFR 11 (Part 11) remains limited. Gaining a better understanding of the purpose, scope and components of Part 11 will help sites achieve that goal.
The FDA defined the requirements for paperless management of regulatory information in 1997, with the specific aim of encouraging the adoption of electronic solutions. The FDA website offers several different inspection observations related to organizations that are not in compliance with Part 11. Those observations represent a collection of best practices that can be implemented to help protect the integrity and security of the regulatory information for which you are responsible.
While not easy, the journey to compliance can improve the research site in many ways. Overall, it can bring better SOPs, happier staff, and a more efficient research site.
7. Be Prepared for Sponsor Resistance
Sponsor push-back is among the most common areas of concern for sites and institutions. “When we first rolled this out I thought, ‘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,” Jill says. Federal regulations make the regulatory binders Jill’s responsibility. “But if it doesn’t work for the study sponsors, they’re not going to continue placing studies with me. So, I wanted to make sure they stayed happy.”
When moving to a document management system, sites should determine in advance which record(s) 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.
The next step to gaining sponsor acceptance is to demonstrate to the monitors how the system will benefit them. According to Jill, their monitors eventually 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 says, 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,” says Jill.
Transitioning to a paperless system is a process, but with the right guidance, it can be quite smooth. For more insights and experiences from sites transitioning to a paperless process, access the featured case studies “eRegulatory Experiences from a Site Without Binders” and “More eRegulatory Experiences: Embracing a Paperless Process for Your Site”.