Supporting Staff Through Regulatory Digitization

It’s often said that an organization’s greatest resource is its people. Clinical research offices couldn’t exist without the clinical, recruitment, financial, or other members of its staff — they are on the front lines for excellence in patient care and at the forefront of ensuring life-saving treatments get to market throughout the globe. So when your clinical research organization is considering important operational changes, engaging and supporting staff should be a main priority. This is especially true as you make the shift from outdated paper regulatory binders to easily accessed digital files for regulatory management. Sites that have shifted to digital solutions for regulatory management have optimized resources, freeing up staff time to focus on patient-care and revenue-producing tasks that maximize productivity, accuracy, and profitability. These transitions will likely be seen by staff as positive, but it’s critical to ensure they understand the process, timeline, and expectations during the transition.  

Traditionally, important regulatory information has been stored in a series of massive, heavy binders. Moving to a digital regulatory system or “eBinder” frees up space and time, but keep in mind that some staff members are extremely comfortable with the paper system and might even feel their job is at risk with a move towards digital records. Engage the team that manages regulatory compliance to plan the transition together. Have them determine key deliverables, activities, and timelines to transition binders to your new eRegulatory system. Ensure they are part of training and eClinical configuration planning so that when the time comes to make the final switchover, they’re fully on board and understand their important role in the project.  

Don’t forget to manage ongoing communications around the digitization efforts with your staff. Conduct both in-person and e-communication updates on items like timelines, functionality, training, and other critical convergences between their everyday work and the digital regulatory changes. Ensure the team understands how digitizing their regulatory binders will affect their workload when it comes to CRA site visits and FDA inspections. Digital records will make preparing for inspections less time-consuming and potentially reduce the amount of time inspectors are on site. By highlighting benefits they’ll actually experience, staff will better understand the regulatory transition to digital records. 

Another important consideration is a reward and recognition system specifically tied to the eRegulatory transition. Staff members will be more likely to adopt and learn the system if their efforts are rewarded. Remember, they will be transferring paper records to digital and learning the new system, all while accomplishing routine tasks as part of their current workload. Listen to their concerns and answer any questions that they have. Even something as simple as a verbal thank-you can help in the midst of a challenging time. A weekly snack break or coffee run for everyone, courtesy of the implementation team, keeps momentum lighthearted and alive. 

Clinical research offices need to ensure staff support and development during any significant operational change and digitizing regulatory management is no exception. Check out our latest guide “Five Steps for Digitizing Regulatory Management” to help you navigate the transition. If you need help selecting the right system and transitioning your work processes, request a demo of our powerful eReg or other eClinical solutions.

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