Contributed Commentary by Angela Gill Nelms 

September 9, 2020 | Standardized vocabulary in clinical research operations is essential. When a simple misplaced decimal point or number can mean life-altering implications, this level of standardization is required.

Over the last six months, the industry rapidly accelerated timelines for conducting research in remote environments, but the terminology did not keep up. Clin-ops leaders are poring over dozens of publicly available webinars, eBooks, and guides as they seek to prepare for remote powered studies—and each has slight variations in its descriptions.   

Because we work with industry leaders across research sites, sponsors and CROs adopting remote site monitoring platforms, this industry language is particularly relevant for us. To help our team, we conducted surveys and documented 1:1 conversations with the research community while they work to shape an entirely new approach to clinical research operations. 

As a result, we were able to develop precise and consistent terminology for use internally. The following list defines ten buzzwords that rose to the top in our research and that you should know as you explore solutions for virtual and remote clinical trials. 

1. Centralized Clinical Trial (CCT): When researchers conduct a clinical trial by collecting data from patients in a centralized location (site).
   
2. De-Centralized Clinical Trials (DCT): When researchers conduct a clinical trial by enrolling, consenting, monitoring and collecting data from patients in their homes using digital tools and devices. Researchers may also deploy ambulatory care teams and may direct participants to regional or central labs for infusions and labs instead of requiring participants to visit a traditional centralized research facility (site). Also Called - Remote Clinical Trials and Direct-to-Patient Clinical Trials 
   
3. Virtual Clinical Trial (VCT): A subset of de-centralized trials that are fully virtually-enabled with digital tools and devices, requiring no face-to-face patient to researcher/PI interaction. Medical devices, eClinical solutions and video visits are commonly deployed to facilitate VCTs.
   
4. Hybrid Clinical Trial (HCT): When researchers conduct clinical trials while deploying strategies from both CCT and DCT methodologies to enroll, monitor and collect data from patients.
   
5. Remote Site Monitoring (RSM): When a Monitor conducts a review of the site’s Investigator Site Files (ISF) and drug accountability through digital platforms without physically visiting a research site. Strategies may include accessing documents via electronic Investigator Site Files (eISF), electronic document management systems, data warehouses, faxing, portals or email. Drug accountability may be facilitated via virtual video visits and other digital technologies. Also called – Virtual Site Monitoring
   
6. Remote Source Document Verification (rSDV): When a monitor conducts SDV using digital platforms instead of verifying source data via paper-bound processes. eClinical, EMR, eTMF, eISF and email may be directly integrated to support remote monitoring on a single platform. Alternatively, researchers can remotely access EM/HRs, eClinical solutions, portals, data warehouses, faxing and email individually to exchange documents.
   
7. Home-based Monitoring: A type of Remote Site Monitoring (REM) where the monitor is working from their home using remote monitoring tools and processes. REM and rSDV solutions eliminate or reduce the need for Monitors to visit sites.
   
8. In-house Monitor:  When a Monitor works at the CRO’s or sponsor’s offices. REM and rSDV solutions eliminate or reduce the need for monitors to visit sites.
   
9. Risk-based Monitoring (RBM): A methodology of monitoring sites on a schedule that is governed by a risk trend analysis. The analysis provides information identifying areas of highest risk for the study, including protocol deviations and safety concerns. A monitoring schedule is customized around these metrics. Typically, RBM strategies reduce the number of site visits in lower-risk studies.
   While RBM is inherently more economical by reducing in-person site visits, REM and rSDV can further enhance the economy of RBM.
   
10. Electronic Investigator Site File (eISF): At the core of remote site monitoring is the eISF. This approach to site monitoring is drastically different from the previous attempts at site portals. In this scenario, the research site manages the full study life-cycle on the platform, including completing regulatory documents, storing source documents, placing compliant eSignatures, and working with the sponsor/CRO for quality assurance.
    

The industry continues to evolve rapidly, with most experts predicting that COVID-19 accelerated the shift to remote site monitoring by 3-5 years. New terms will continue to pop up as the industry gains a better understanding of the requirements and opportunities in remote powered research.

Angela Gill Nelms brings more than 15 years of clinical research experience in over 50 trials partnered with more than 60 US and European hospitals. As the Chief Operating Officer at Florence Healthcare, Angela is charged with strategically guiding the direction of the company, creating a “Best Place to Work” culture, driving core products, ensuring successful product implementation, delivering white glove customer service and making sure clinical teams around the world are successful. In 2016, Florence had one customer and now serves 7,300+ clinical researchers through its innovation. She can be reached at angela.nelms@florencehc.com.