High Percentage of Subjects with PDs related to in/exclusion criteria (kri)

High Percentage of Subjects with PDs related to in/exclusion criteria (kri)
Type of indicator Performance
Risk Category organizational experience
Golden KRI NO
Therapeutic Area General
IF Risk-Event a site is not adhering to the protocol
DUE TO Risk Causes various reasons
THEN Risk Impact MAY RESULT difficulties for the statistical analytics and jeopardy of data usability
Risk Indicator High Percentage of Subjects with PDs related to in/exclusion criteria
Metric Percent of Subjects with PDs related to in/exclusion criteria
Unit %
What level should be measured Study, Country, Site
Comments Can be calculated if for every eligibility criterion in the current status of the protocol there is a record in the database (regardless of I/E Criterion Result field value). That is guaranteed by EDC.
Purpose To detect whether there may be issues with the screening process and participants being enrolled when they should not have been. Suggests there may be issues with protocol adherence at the site. At study level, it can detect the risk of sites finding it difficult to apply the inclusion/exclusion criteria and the risk to the ability to draw a useful conclusion to the trial.
Description KRI monitors the risk of a high level of participants being enrolled who did not meet the inclusion/exclusion criteria according to entry in EDC. It alarms if the percentage of those enrolled who do not meet inclusion/exclusion criteria is high relative to other sites.
Formula For each randomized Subject (with randomization status 'Yes') check Inclusion/Exclusion criteria of that Subject. If any Inclusion criterion has answer 'No' or any Exclusion has answer 'Yes' then count the subject as not meeting the eligibility criteria. If there are answers for a same criterion in the different versions of the protocol are present, then that check is performed for every version of the criterion. The resulting count of Subjects is the metric value devided by a total number of randomized Subjects, multiply by 100%.
Suggested Thresholds - High >3 %
Suggested Thresholds - Medium >2 %
Associated Metric 1 Number of randomized Subjects
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