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.