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Compliance In Focus
Posted by Elizabeth Braschayko on Tue, Apr 6, 2021

Considering a Hybrid Approach To Research? Answer These Critical Questions First

 

As more people become vaccinated, many clinical researchers may soon resume on-site activities if they haven’t already.

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However, it’s not likely we’ll return to exactly the way things were before. The way we work has changed. Our own research shows nearly three-fourths of clinical research professionals believe a hybrid approach that includes both on-site and remote activities will be the best way forward.

To ensure a successful transition, take some time to address these critical questions first.

9 Questions To Consider For A Hybrid Approach

1. Which activities are better remote and which are better on-site?

This will depend on the risks involved, the patient population, and the sponsor and sites’ resources. Sponsors can determine if any of their sites can obtain electronic consent or complete follow-up visits via 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.

Some activities that may be better suited for remote monitoring include:

  • Enrollment procedures
  • Adverse event reporting and follow up
  • Investigational product disposition
  • Follow-up visits
  • Subject questionnaires

2. How will we manage secure file-sharing?

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. Some additional considerations include:

  • Does your file-sharing system include password protections?
  • Can you revoke access if a file is inadvertently shared with the wrong person?
  • Is the system compliant with 21 CFR Part 11 and/or with HIPAA requirements?

3. How will we manage electronic consent?

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

Two examples of systems that can be 21 CFR Part 11 compliant are Adobe-Sign and ShareFile.  The FDA’s MyStudies app also allows investigators to send informed consent documentation electronically to patients.  

4. How will we store clinical trial data securely?

Many sponsors and sites already use an electronic data capture system to store data, but it’s worth considering whether your existing system meets your needs. For instance:

  • Does it allow you to securely upload patient data from wearable devices, such as fitness trackers?
  • Does it record the origin of the data?
  • Does it protect records throughout the retention period?
  • Does it maintain an audit trail?

5. How will we protect personal health information?

If sites have team members reviewing medical records from home, they may need to update policies to protect patient privacy. That includes requiring that only designated individuals may review medical records at specified times and through a virtual private network (VPN) rather than a wireless internet connection. These policies may need to extend to sponsors and monitors to ensure there are procedures in place to protect protected health information.

6. How will remote activities impact our study budget?

While remote monitoring, remote auditing, and other activities eliminate travel costs, they may introduce new costs. You may need to invest in new technology to manage activities remotely or account for the additional time it takes to prepare for remote visits.

Be sure you consider that as you establish budgets for future studies.

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7. Will we need additional training?

In our survey, clinical researchers cited “ensuring compliance” and “ training teams to use new technology” among their top three most significant challenges of adopting a hybrid approach.

To make this model successful in the future, you may need to consider additional training in the fundamentals of clinical research compliance, as well as specific topics like how to manage electronic consent.

8. How will we maintain safety at our clinical research sites?

As sites begin allowing more on-site visits, sponsors should communicate with their sites to determine what safety measures they need to maintain a safe environment. For instance:

  • Is there a limit to the number of monitors allowed on-site at one time?
  • Are monitors required to wear masks throughout the visit and/or complete any additional safety precautions, such as COVID testing?  
  • Does the site have the ability to set up private conference rooms where monitors can work at a distance?
  • How will we clean and sanitize shared surfaces?

This checklist, based on the FDA’s guidance for conducting clinical trials during COVID-19, can help you reopen sites safely.

9. Do we have the resources we need to manage a hybrid approach?

Managing both on-site and remote visits brings additional challenges and may require more support. You may need to hire additional monitors, for instance, or enlist the help of a project manager if you don’t already have one.

IMARC Can Help You Master The Hybrid Approach

As a medical device contract research organization (CRO), IMARC offers an experienced, objective perspective on how to navigate these changes. We can review study documents remotely or in person to ensure they align with FDA standards.

We can also assist with on-site or remote monitoring, auditing, project management, and data and safety management. And if your team needs additional training, we can develop a customized curriculum to meet your needs.

To learn more about how we can help you adjust your strategy for this new era of hybrid clinical monitoring, contact us today.

Topics: Clinical Monitoring

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