Key Risk Indicators (KRIs) for Clinical Trials

Key Risk Indicators (KRIs) for Clinical Trials2016-11-16T18:35:20+00:00

What KRIs are available for a clinical trial?

KRIs available in Cyntegrity’s RBM Cloud Solution and for licencing to third parties.

Each of the module consist from the number of specified, validated and proven KRIs.
All of them are CFR 21 part 11 and GCP compliant.

KRI Sets Available in Cyntegrity’s RBM System

Data quality is the next stage after the fraud check. This KRI set can identify systematic factors, which influence the precision of data capturing. KRIs fire an alarm, when, e.g., data has unexpected distribution or has too low variance.
Performance of a clinical trial is the complex topic. It can mean performance of sites, central labs or even performance of data management department. This KRI set focuses on patient recruitment questions. It builds a mathematical model of including in a trial and can already in 1-3 first month forecast with 80% of probability, how good the performance of recruitment will look like.
How good your CRF covered? What proportion of missing data is inside?
The quality of data, speed of data transfer, proportions of missing information influences the site quality benchmark.
ECG Lead misplacement, too high signal noise in ECG, signal defects, etc. could be identified by these modules.
Bad Calibration, errors by measurement taking
How good is your Spirometry measurement? Does it fit into latest ATS criteria? Was certain event (like coughing) disturbing the quality of taken maneuvers?
Was a patient attentive while filling up a questionnaire? Is the data trustworthy, does integrity exist?
Do you have some risk, you would like to control in the upcoming trial?
Did you have any risk event in the past, which you would like to avoid in the future? Tell us and we realize them in a KRI.

Each of the KRI is tested based on retrospective method using real and artificial data. For the development of them we used industry standards, knowledge of industry experts and opinion leaders as well as findings by our internal KRI lab. Our KRI Lab consists from experts (mostly of PhDs), who worked for a long time as CRAs, lead CRAs and clinical project managers.

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