Business Continuity Plan for Clinical Trial Sites: Why Electronic Source Matters During COVID-19

The impact of COVID-19 on clinical trials has likely become obvious for your site during this phase of the pandemic. Sites are struggling with screening holds, limited staff, an influx of sponsor requests while staff is not on-site, the challenge of retaining enrolled subjects, and more. It is now more important than ever to implement a business continuity plan for reopening your clinical research site. Be prepared for potential new waves of COVID-19 that could result in individual staff members being quarantined or the site having to take precautionary measures. This means that on short notice the site must be in a position to limit patient-staff interactions, and ensure that the PI and Sponsor representatives have remote access to patient data.

Before joining Clinical Research IO, I was a manager at a women’s health site. I oversaw the selection and implementation of the CRIO eSourceeRegulatoryCTMS system at my site. I knew this was the right decision because it allowed us to control quality and improve efficiency. But when the pandemic hit and we had to modify our procedures, I really knew that we had made the right decision. Unlike many sites I knew, we were able to adapt very quickly to the new circumstances, maintaining our productivity while enabling remote monitoring for our sponsors.

With CRIO, the system fully integrated all of our modules into one log-in: Scheduling, eSourceeRegulatory, Finance, and Recruitment. We could collect data electronically during the visit and then review and query that data remotely and in real-time. We could give read-only access as needed, and restrict access to different modules to different users. We could give our monitors instant access only to the studies they were assigned to and view and respond to their queries remotely. These capabilities became life-savers when we had to institute work-from-home and prohibit monitors from visiting our site.

Even though parts of our country are opening up again, most epidemiologists are forecasting future waves of the pandemic, which could necessitate many of the same measures sites have recently undertaken – work-from-home, virtual visits, restricted monitor travel, etc. Having CRIO implemented at your site will allow you to adapt instantly to these changes.

Here are the things we were able to do with CRIO during the pandemic:

1. We easily minimized the number of research site staff who had to be onsite:

    • Coordinators took separate shifts that did not overlap. When one person was in the office seeing patients, other personnel could be at home, doing EDC entry, answering queries, processing regulatory documents or documenting phone call visits to patients.
    • Our investigators could stay home and enter progress notes, conduct phone visits and record the source in real-time, and sign off on labs and visit notes.
    • Our finance person could track receivables in real-time, as the data was being completed, and send invoices in a timely manner so as to maintain cash flow. We could see in an instant which invoices and visits were overdue on payment, and take appropriate follow up.

If you’d like to learn more about how CRIO-enabled clinical trial sites are allowing their staff to work remotely, schedule a demo with our team to learn more about how CRIO’s CTMS.

2. CRCs, Lab staff, and Investigators had access to the subject chart at the same time.

PIs could write a progress note immediately after seeing a patient while the CRC finished the visit. Lab techs were able to document blood draw times while the coordinator uploaded relevant visit files.

3. We were able to give our CRAs remote monitoring access at any time.

Our CRAs could view our data and leave their queries behind, and we could respond to and close out those queries from home. By the way, because of the built-in edit checks, we had a lot fewer queries to address, and saved a lot of time not having to scan and email source in.

4. We were able to adapt our eSource on the fly.

This way we could complete certain procedures on-site and certain procedures, and/or visits remotely. We were able to implement virtual visits and at-home deliveries of IP by creating appropriate procedures, adding them to our library, then adding them as needed to the appropriate studies.

5. We used CRIO’s automated text reminder feature to add COVID screening questions…

And a reminder to patients to wear a mask to their visit!

6. We could build and add a COVID-19 screening questionnaire per CDC guidelines (temperature check, etc.) to the beginning of each study visit.

Using that screening questionnaire, we could then generate an invoiceable charge to the sponsor, if that’s what our clinical trial agreement allowed.

No one could have predicted that we would be dealing with something as disruptive and devastating as COVID-19. Having CRIO really allowed us to adapt our processes while maintaining data quality and PI oversight. Based on this experience, I became such a strong advocate of the CRIO system that I joined their team – my job is to help other sites implement the system and gain the efficiencies I experienced firsthand.

If you’d like to learn more, you can talk directly to our team here.

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