Clinical Researcher—April 2022 (Volume 36, Issue 2)

DATA-TECH CONNECT

Mollie Maggied, MSN, MHA, RN, AT-C, CPN; Paula Smailes, DNP, RN, CCRP

 

While technology is known to help with efficiency and productivity for clinical researchers, it can also be accused of leading to feelings of stress, burnout, and being generally overwhelmed.{1,2} Increased work volumes thanks to electronic workflows can be to blame, but staffing crises may also be at fault. Meanwhile, there exists a smaller number of experienced applicants being considered for open research positions across the drug and device research and development industry.{3,4}

That said, when the perfect applicant is hired, there may be a tendency to expedite onboarding. From the site perspective, there are obvious considerations with onboarding, such as adding new hires as staff on institutional review board (IRB)–approved research and providing training on the protection of human subjects.

Adding to that, the technology needs for today’s clinical research staff are equally essential. When new hires onboard, access to technology becomes critical to perform daily workflows. Central to that are communication, such as e-mail, and data sharing (e.g., via electronic case report forms). While technology considerations are important to onboarding, they are crucial throughout the duration of employment to offboarding. Even internal transfers may have technology changes as they move from one position to another.

Onboarding

The Joint Task Force for Clinical Trial Competency (a collaborative effort of representatives from many organizations, including ACRP, managed by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard) has identified data management and informatics as key skills that clinical research staff should possess.{5} When applying this philosophy to new staff who are onboarding, access to technology should be one of the most important considerations. Given the needs and complications of standard operating procedures for using company e-mail and shared drives, electronic case report forms (eCRF), IRB portals, virtual meeting platforms like Microsoft Teams, Zoom, and WebEx, plus the electronic medical record (EMR) system, access becomes crucial to daily operations.

Consider the revenue cycle aspect of conducting research. Are billing systems available for sponsor or patient payments when access becomes critical? Is scheduling software ready for patient appointment–related tasks?

For some systems, such as those tied to eCRFs and EMRs, training also becomes a priority. Ideally, training will occur close to the beginning of the end-user’s first official use of a system, so as to not leave him or her forgetting the system features that were taught. If the system is complex, use of a playground environment, if possible, can increase confidence until access to the live system becomes possible.

Meanwhile, since the onset of the pandemic, the use of telehealth has skyrocketed, including in clinical trial situations. Telehealth has become a much more widely used means to conduct clinical research visits and another system to which new hires require orientation.{6}

Consider the use of a checklist that includes both the technologies that the new hire needs oriented to, but also a competency checklist, to ensure that new hires have a basic understanding of both how to use the systems and how to apply any efficiency tools that may exist.

Offboarding

Why is this important if the research staff are transitioning into a new role in the organization or leaving it altogether? The answer lies with the consequences that may exist without a properly executed exit plan. There needs to be assurance that nothing is left undone, and while technology access has stopped, communication channels must continue. The following tasks, explained in more detail afterward, should be considered when an employee is leaving an organization or is an internal transfer leaving a research role:

• Remove research staff from being listed in research protocols when there are system impacts, from inclusion in organizational drives and e-mail systems, and from access to sponsor systems.
• If electronic documentation was used, ensure that any final research notes and encounters are signed.
• Place an “out of contact” message in e-mail and the EMR communication tools for staff who are leaving, along with guidance for whom should be contacted for future operations.
• Perform a messaging system “cleanup,” including e-mail and EMR systems.

Removing Staff

If the EMR has research notifications based on protocols, there can be concern if staff members are not removed from studies upon leaving the organization or transitioning to new roles. If staff become internal transfers, alert notifications may continue to fire to them for patients on studies for which they are no longer covering. This could lead to Health Insurance Portability and Accountability Act (HIPAA) violations if study staff are no longer involved in patient care per protocol.

Staff who leave will need to have their replacements added as soon as possible to ensure communication continues for the study, regardless of technology medium. It is imperative these steps are taken to avoid issues.

Unfinished Notes and Encounters

Another possibility from research staff departure exists when notes are not signed by the research staff if the documentation method is electronic. This could result in incomplete notes being placed in a pending status that eliminates the possibility of other staff members being able to view unfinished work. Open notes could lead to open encounters in EMR systems, which could inevitably result in incomplete data for the research study. Given this consideration, protocol deviations or violations may be the ultimate negative outcome.

Messaging

Ongoing communication about coverage is important in that it allows people to know who is covering upon any departures of staff. Thinking of the multiple systems that clinical researchers use, how many have a built-in messaging feature? For EMRs, an internal messaging system allow users to message other system users, keeping the dialogue secure within it. However, e-mail is just as important. Setting up an away message for the end-user who is leaving will allow others to contact the correct person if there are questions. It also ensures continuity of research-provided care. If the system allows, providing a start and end date can facilitate staff coverage. This process allows for a coworker to continually monitor incoming communication that are sent to the departing research staff.

Related to system messaging, it is important that the departing staff member have all messages acknowledged and reconciled. This ensures there are no outstanding issues requiring their attention. This also allows for the covering coworker to not be inundated with old messages that still may need attention after a staff mate’s departure. Having the researcher clean up and handle messages and tasks within the system prior to his or her departure is in the best interest for all users of the system.

Conclusion

Technology has evolved into the backbone of clinical research operations. As we grow accustomed to electronic systems to execute daily workflows, how staff are properly oriented to systems will lead to faster functioning in their assigned roles. Offboarding is just as important to assure that there is no unfinished work and ensures a continuous flow of operations and smooth transitions when staff depart. If your organization has an informatics department, consider soliciting its help to facilitate and support staff during these times.

References

1. Harper B. 2020. Capacity and Competency of the Clinical Research Workforce: Today and Tomorrow. Clinical Leader. https://www.clinicalleader.com/doc/capacity-competency-of-the-clinical-research-workforce-today-tomorrow-0001
2. Causey M. 2021. Burnout Threatens to Undermine Clinical Trial Workforce Productivity. https://acrpnet.org/2021/09/13/burnout-threatens-to-undermine-clinical-trial-workforce-productivity/
3. Aerotek. 2018. The Staffing Crisis in Clinical Trials and the Drive for Permanent Staff. https://www.aerotek.com/en-gb/insights/the-staffing-crisis-in-clinical-trials-and-the-drive-for-permanent-staff
4. Kremides J. 2017. A Turning Point: Examining the Clinical Research Workforce in 2018. https://www.outsourcing-pharma.com/Article/2017/12/21/A-turning-point-Examining-the-clinical-research-workforce-in-2018
5. Sonstein S, Jones C. 2018. Joint Task Force for Clinical Trial Competency and Clinical Research Professional Workforce Development. Frontiers in Pharmacology 9:1148. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6198073/
6. Lorusso D, Ray-Coquard I, Oaknin A, Baberjee S. 2020. Clinical Research Disruption in the Post-COVID Era: Will the Pandemic Lead to Change? ESMO Open Cancer Horizons 5:5. https://www.esmoopen.com/article/S2059-7029(20)32718-6/fulltext

Mollie Maggied, MSN, MHA, RN, AT-C, CPN, is a Clinical Informaticist for The Ohio State University Wexner Medical Center, specifically supporting oncology research.

Paula Smailes, DNP, RN, CCRP, is a Senior Systems Training and Optimization Analyst for The Ohio State University Wexner Medical Center and Principal Trainer for clinical research. She is also a Visiting Professor for Chamberlain College of Nursing and a member of the Content Advisory Committee of ACRP.