Risk Indicator Design

Risk Indicator Design

If you want to achieve the quality and cost saving benefits that risk-based monitoring can offer, but are not sure which risk indicators are best suited to your trial then we are here to help. TRI offer a complete Quality Risk Indicator (QRI) design service. Our expert consultants all come from clinical operations backgrounds and are experts in designing and running clinical trials using the risk-based monitoring approach.

Our Indicator Design Process

At TRI we believe that study quality begins right at the protocol design. We assess the risks to the protocol itself, the risks around the critical data and the processes in collecting that data.

risk assessment process

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We analyse the clinical trial processes to determine how the trial is being conducted and what the likely risks to quality and consistency across all sites are likely to be. For each area of the trial we want to be able to measure remotely we design an indicator specific to that area, determine the best way to visualize that data, assess which statistical model will best identify outliers for that indicator and then document that design, so that it can be fully validated. TRI’s RBM platform, OPRA is then able to consume that design and generate the indicator dashboard automatically, or the indicator design document can be turned over to you to incorporate into your own RBM system if you have one.

Core Indicators vs. Study indicators

Based on both regulatory guidance and the experience we are gaining from the market place, and our customers specifically, we are seeing a trend towards the use of general (or Core) indicators which are used across all studies, and study specific indicators.

KRI types

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We really like this approach as it allows companies to get a broad based view across multiple studies of site quality by using the core indicators consistently across all studies. At the same time it allows very specific, sensitive assessment of study processes, and risks to critical data on a case by case basis. We believe this approach offers companies the best of both worlds, and is core to our consultation approach.



To find out more about our indicator design service, other RBM services and our OPRA risk-based monitoring platform, contact us today on info@tritrials.com