The COVID-19 pandemic has dramatically changed clinical research as we know it, forcing many clinical researchers to re-evaluate their priorities.
Risk-based monitoring can help sponsors determine which activities are most important, based on the study design, the study population and other factors.
Here’s a closer look at what’s involved in risk-based monitoring and what sponsors, sites and monitors should consider as they make adjustments for this “new normal.”
What Is Risk-Based Monitoring?
Risk-based monitoring (RBM) focuses on identifying the most likely risks to patient safety and data integrity and developing a specific monitoring plan to address them, according to the FDA’s guidelines.
It starts with a risk assessment to identify important risk factors, including:
- The complexity of the study design
- Types of study endpoints
- The vulnerability of the study population
- The experience of the investigative site(s)
- The risks involved in the product
- The quantity of trial data needed and how it will be collected
Based on these factors and others, sponsors should develop a monitoring plan that specifies the timing, types and frequency of monitoring activities.
A risk-based monitoring plan should also address how to:
- Identify and report protocol deviations
- Implement corrective and preventive action plans
- How to document and communicate monitoring findings
- Ensure monitors have proper training
- Confirm that the study is randomized according to protocol
Centralized monitoring and quality data management are other important aspects of this approach. Having all your critical data in one platform and a consistent process for data review makes this much easier.
How Can You Adjust Monitoring Activities Now?
Risk-based monitoring isn’t new, but the global pandemic has prompted sponsors and sites to adopt this approach if they haven’t already. They are focusing on the most essential monitoring activities and whether they can be conducted remotely to keep clinical operations moving forward.
You’ve probably already made some significant changes to your study protocol, including adopting more remote research activities.
For sites, that may mean conducting follow-up communications with patients using video chat or email. It likely means implementing COVID-19 screening procedures for on-site monitoring visits as well.
For sponsors, adjusting to the “new normal” also means adopting a more flexible approach for collecting site data, including modifying protocols to allow for follow-up data to be collected remotely, and postponing and/or removing requirements for assessments that aren’t crucial.
Monitors should work with sponsors to make the necessary adjustments and ensure everything is documented clearly, including activities that cannot be completed.
Consider the risk-based monitoring framework as you make these decisions. While you may be able to use a fully remote monitoring plan for some trials — especially those for low-risk devices — the risks may outweigh the benefits in others.
How Should You Adjust Your Future Monitoring Strategy?
Although the world is anxiously awaiting a COVID-19 vaccine, it could be another year before it is widely available. In the meantime, there are many other long-term factors you’ll need to consider as you adjust monitoring activities.
Here are three important questions to ask as you expand your risk-based monitoring approach to include COVID-19 considerations.
How will you manage documentation?
Whether you plan to return to on-site activities, continue remote activities or use a combination of both, documentation is a critical component. If you currently rely on paper documentation, it may be time to invest in a HIPAA-compliant electronic data capture system.
You may need to ask patients to use electronic signatures for consent and write digital diary entries, rather than completing paper worksheets.
You will also need a secure file-sharing system.
How will you manage travel?
Many studies have limited all but essential travel these past few months.
For monitors, contract research organizations or other parties who do need to travel, you may need to provide additional documentation about the purpose of their visit.
How will you protect patient privacy?
Remote monitoring can introduce potential privacy violations if it isn’t done carefully. Research staff who review patient records remotely need to do so only from private locations, using a password-protected Internet connection.
Sites and sponsors need to adopt procedures to ensure patient confidentiality in remote environments. Sites should require sponsors and monitors to sign agreements stating they will adopt this protocol.
How IMARC can help with remote monitoring
Although remote monitoring may be new to many sponsors and sites, our team has been doing it for years. Despite all the challenges of navigating this “new normal,” we have helped sponsors and sites successfully pivot during this time.
For instance, we helped several sites with remote close-outs to ensure they would complete their trial on time and on budget. We used file-sharing systems to share unredacted source data and regulatory documents to allow monitoring activities to continue remotely.
In another example, we conducted a remote audit to help a sponsor prepare for a FDA BIMO inspection.
Our team also offers remote clinical research training your staff can take at their convenience. This ensures everyone has a solid foundation of regulatory knowledge and follows a consistent process across your clinical trial.
To learn more about how we can help you adjust your strategy, contact us today.