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Compliance In Focus
Posted by Kelly Schindelholz on Tue, Mar 30, 2021

Does Remote Monitoring Really Save Time?

More than a year ago, we were all thrust into this remote monitoring world. There seems to be a perception that remote monitoring reduces clinical trial costs and saves time.

remote-monitoring

While this can certainly be true in some cases, we wanted to take a closer look at how remote monitoring has been impacting clinical trial costs and time.

We conducted a survey of more than 100 research professionals to find out what the experience has been like. We recently published a detailed overview of the results and encourage you to download the report for a deeper dive.

We found that there is an obvious automatic time savings when you remove the travel component of the visit. However, it might be surprising to know that the remote nature of the visit doesn't necessarily reduce the overall time it takes to prepare for and/or conduct the visit.

Here’s what we learned.

How does remote monitoring impact the time spent preparing for visits?

In general, our survey showed remote monitoring typically adds to the time spent preparing for visits.

Thirty-three percent say it significantly increased prep time, while another 25% said it slightly increased the time they spend getting ready for a visit.

Fifteen percent say it has had no impact on prep time.

A much smaller percentage (18%) say their teams are spending slightly less time preparing for remote monitoring visits, while 15% said the decrease in prep time was significant.

How does remote monitoring impact the time spent conducting visits?

While many initially believed remote monitoring would save them time, more than half of survey respondents say this has not been the case.

Twenty-nine percent say it has significantly increased the time they spend during visits, while 27% report a slight increase. However, 35% say it has slightly decreased the time spent during visits, while 8% say the decrease has been significant.

Why does it take more time to prepare for and conduct remote monitoring visits?

We attribute the increase in preparation time to several factors. First, many sponsors and sites have not fully digitized their clinical research processes, so they’ve found themselves spending more time scanning and uploading documents prior to visits.

They may also need to implement new processes for collecting electronic signatures for informed consent or using other forms of communication (such as email and video) to follow up with patients.

Not every site has access to a secure file-sharing that is compliant with HIPAA and 21 CFR Part 11, so they may have to de-identify records in some cases.

Additionally, they may still be refining their processes for electronic data collection and review. Preparing for remote visits often means managing secure access to a database for several team members and establishing workflows to ensure compliance.

That includes establishing appropriate protocols for who may review data and how to make corrections without overriding existing information. In some cases, this may require additional training.

Finally, sponsors and/or sites that have pivoted to remote monitoring may have certain activities they are unable to perform. Per the FDA’s guidance for conducting research during the pandemic, they need to make note of any activities outlined in the original study plan that they did not perform. If they used alternative methods to perform them, they need to include detailed descriptions of what they did instead.

All this adds to the time they spend conducting remote visits.  

How can researchers make remote monitoring visits more efficient?

Having conducted remote monitoring visits for years before it became a necessity, our team has a few recommendations to help you save time.

Determine which activities should remain remote vs. in person

Now that vaccinations are becoming more widespread, it’s a good time to think about reopening research sites if you haven’t already. While some remote activities can save you time and money, others may be more efficient and effective in person.

Consider the risks involved, the patient population, and the sponsor and sites’ resources. For instance, sponsors can determine if any of their sites can obtain electronic consent via text messaging, phone calls, videoconferencing, or live chat with a remotely located investigator.

Sites should work with their IRBs to receive approval for any of these modified patient procedures.

hybrid clinical monitoring

Consider the best ways to maintain study data

Sponsors should consider setting up their own secure file-sharing system for sites and monitors to transmit and review source documents. When using a file-sharing system, it is important to determine ahead of time how to manage it securely, protecting subject and study data.

You will want to consider whether the file-sharing platform includes password protections, the ability for a sponsor to revoke invitations if a file is inadvertently shared with the wrong person, and whether the system is compliant with 21 CFR Part 11 and/or with HIPAA requirements.  Two examples of systems that can be 21 CFR Part 11 compliant are Adobe-Sign and ShareFile.  

Sponsors should also think about different ways for study data to be transmitted or obtained.  For example, subjects could submit electronic diary entries instead of completing paper worksheets that need to be collected by site personnel.  If subjects are using wearable devices that collect data, there are ways to ensure these are properly sorted and stored. They could also upload source documents or worksheets for review within an electronic data capture (EDC) system.

Sponsors should ensure that the electronic database capture (EDC) system has commercially available e-consent solutions that comply with 21 CFR Part 11.  

Consider setting up an electronic version of your Trial Master File

While having sites send regulatory documents to sponsors and/or monitors may work in the short-term, this is not efficient or practical long-term.  Sponsors should consider setting up an electronic version of the study Trial Master File. Think about who will need access, how you will maintain it, and how you will protect the files.  

While it can be beneficial for sites to upload regulatory documents directly into the system, it may make sense to have designated study staff who ensure files are named and filed consistently.

Get help from a CRO

While remote monitoring can often be more cost-effective and convenient, transitioning to remote activities may require additional time and effort. Our own research shows most sponsors and sites plan to implement a hybrid approach that combines remote and on-site activities in the future.

An experienced contract research organization (CRO) can provide additional support for both remote and on-site monitoring so you can keep your trial moving efficiently.

IMARC can provide additional monitors to reduce your team’s workload, manage safety monitoring boards, assist with project management, or train your team in best practices.

To learn more about how to adjust your clinical trial planning to support the new hybrid approach, download our latest whitepaper.


Topics: Clinical Monitoring

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