We got a number of great questions during our recent webcast, Risk Based Monitoring: A Technology Amplified Approach. As such, I wanted to take a few moments to provide feedback.

Risk Based Monitoring Plans

We have a Risk Based Monitoring Plan that is designed to guide remote visits, and remote visits and information with critical variables that require onsite SDV is our process. Could this reduce the chance of queries and what is the number that can be reduced?

The database at certain data points can be designed so that the person entering the data cannot proceed if certain points are out of range requiring changes prior to moving forward. This is one way to decrease queries.

During the risk assessment, a threshold can be determined on what is an acceptable query rate per site, per study. When this threshold is reached then a decision needs to be made. Define what action needs to be taken once the root cause has been determined. With early detection, this can decrease query rates per site and across all sites.

How do you plan an effective risk based monitoring strategy?

The monitoring plan will need to include trial-specific instructions and rationales on the types of monitoring. It will need to address both on-site and centralized monitoring, including triggers that will increase or decrease the different types of monitoring. A well-defined risk assessment specific to the protocol and timeline when assessments will occur needs to be outlined.  The plan should also include defined risk thresholds and actions required. This can be done in a decision tree approach, and can be programmed into the data system.

One of the greatest challenges in remote monitoring is the assessment of risk based on what we are viewing in eCRFs and other sources. Are there any helpful tools or suggestions you have to determine increased risk that requires an increase in on-site monitoring? Is there a suggested level of risk that is a trigger point for increased oversight?  

Risk assessment tools can be built into the data system. This can include what you will track along with thresholds. Measures like AEs, data quality and compliance can be tracked across the site or study. You can also break these measures down per monitor.  Again, building thresholds in and assigning percentages to what is acceptable – this can be done using high, average and low or a color system such as red, yellow and green.

Staffing and Training

How do you train staff in this risk based monitoring methodology, as it is somewhat counter to what traditional monitors are comfortable with?

Start with the education of the concepts and terminology. Focus on the changing roles related to advances in technology. You need to demonstrate how using a risk–based monitoring approach can increase efficiencies and produce cost savings while maintaining a high level of quality and compliance.

Do you use the same people to do remote and on-site monitoring or do different teams handle that? 

Centralized monitoring allows for a variety of people to be viewing data at the same time. With the utilization of a centralized technology platform everyone is looking at the same data in real-time. Monitors would be responsible for both central and on-site monitoring at their sites.

Site Visits and Risk Based Monitoring

What percentage of monitored visits can be done remotely through risk-based monitoring compared to necessary on-site visits to check physical, non-data aspects (such as container storage, subject well-being, staff competency/training etc.)?

This would be study specific and would be based on the risk assessment performed. Monitoring visits could change as you move through the study and could also change based upon risk findings.

If you’d like to view the webcast, please visit: http://ow.ly/iWtgV.

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