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Remote Monitoring

How Remote Monitoring Has Evolved during COVID

If we weren’t working remotely before March 2020, odds are we had to start. Some of us were more prepared to ‘go virtual’ than others. Prior to COVID, there may have been occasional days we worked from home or did things ‘off site’. Few of us, however, contemplated all the nuanced requirements needed to perform our jobs without being in the office or traveling to the locations of study subjects. Regardless of work sector, we had to consider an overwhelming number of logistics. Everyone had to adapt. 

In addition to study teams who met challenges when switching to remote work, subjects encountered obstacles that prevented them from attending their study visits. Some are still navigating these logistical challenges. Depending on the study’s protocol-specified procedures, subjects may be able to be monitored remotely via telehealth visits, home health professionals, alternate laboratories, and other options approved by the Sponsor and the site’s IRB. However, the studies that require intensive subject monitoring, investigational product preparation and infusion, specialized labs and procedures, and other more subject-intensive variables are not as easily converted to remote trials. 

As a CRO, ProTrials was faced with the need to convert multiple studies from on-site to remote monitoring in a matter of days. We manage a wide variety of studies across vastly different therapeutic areas and in multiple study phases, so the need for flexibility and personalized planning was essential. There was not, and could not be, a one-size-fits-all approach. By design, certain studies lend themselves better to remote monitoring. Some were already remotely monitored as part of their study monitoring plan. But, for those that were not, a determination needed to be made about the capabilities of the Sponsor and each site. 

When determining the feasibility of remote monitoring for a given study, it is important to consider the following: 
  • Which monitoring tasks can be effectively performed?
    • Remotely
    • On-site
  • Which tools are available to exchange data and communicate with the sites?
    • g., SharePoint, Box, e-mail, queries via eDC
  • Which electronic systems are available for study information?
    • Study data, e.g., eDC
    • Enrollment and IP, e.g., IXRS
    • Lab, e.g., vendor portal
    • Study Management, e.g., CTMS
    • Study records, e.g., iSR, eTMF
  • Is there access to electronic subject records (EMR)?
    • Inclusive of:
      • EMR
      • Pharmacy records
      • Document exchange systems
      • Hospital records
    • Can be site dependent and vary greatly between sites
  • What is the timeliness of data entry and data availability? Both study-specified and actual….
    • Can also vary greatly by site

The factors above can vary from Sponsor to Sponsor, study to study, and site to site. They need to be carefully considered before deciding on the best monitoring approach moving forward.

It is equally important to consider a study site’s capabilities for participating in remote monitoring. This can vary greatly within the same study. An individualized approach is often needed.

When determining a study site’s capability for remote monitoring, it is important to consider the following:
  • Will the Sponsor, the site, and the site’s IRB allow remote monitoring of the study?
  • Are there any ‘rules, regulations, or conditions’ that need to be followed to perform remote monitoring at the site?
  • Does additional or special access need to be requested prior to the remote monitoring visit to ensure the CRA will have access to all the appropriate systems?
    • Is special approval needed for this access?
    • How far in advance of the remote monitoring visit does access need to be requested?
    • What are the timeframes during which access is available? (I.e. 2 days before/after the visit days, only on the visit days, only during set hours on the visit days, etc.)
  • Is the site staff agreeable to scheduling teleconferences with the monitor to accommodate the remote monitoring visit as needed for over-the-shoulder EMR review, IP accountability, review of findings with the PI and/or site staff, etc.?
  • Will the site provide de-identified source documentation as needed prior to and during the visit?
  • What data points or percentage of data require SDV?
    • Can the appropriate data be reviewed remotely to ensure subject safety and data integrity?
    • Can subject privacy and data confidentiality be maintained?
  • Is remote regulatory document review possible?
    • Does the site use an eBinder or eISF or a combination of electronic records and paper?
    • Can the CRA gain access to the site’s IRB portal?
  • How will ICF review be completed?
    • Does the site use eConsents?
    • Can ICFs be uploaded into SharePoint, Box, or another similar system for review?
    • Does the site scan signed ICFs into their EMR?
  • How will IP accountability be performed?
    • What information can be verified via IXRS and/or eDC?
    • Is the site using an IP system such as Vestigo? If so, is the CRA able to obtain read-only access? 
    • Is video review of unused drug possible and/or acceptable?

COVID has pushed many of us outside our comfort zones. We’ve had to think outside the box to get things done – especially when it came to keeping our trials going. As COVID numbers are decreasing, many sites are now seeing trial subjects in office again, on at least a modified schedule. However, based on the successes of remote work, site staff are using what they learned to examine alternate ways to care for subjects and perform studies that will be more efficient for all parties involved.

As we all move forward, incorporating remote monitoring into study monitoring plans, making allowances for telehealth visits, and looking at new technologies that allow for ease of subject participation will continue to increase. At ProTrials, we embrace new technologies, building remote monitoring into our studies as appropriate. We continue to work with each of our clients and sites to determine the most appropriate method to ensure data is reviewed promptly, data integrity is maintained, and subject safety, above all, is not jeopardized. ProTrials – the Clinical Monitoring Experts.