High Rate of overall PDs

High Level of Protocol Deviations (PDs)
Type of indicator Performance
Risk Category Organizational Experience
Golden KRI YES
Therapeutic Area General
IF Risk-Event A site is not following the protocol
DUE TO Risk Causes Various reasons such as lack of resources, improper delegation, inadequate training, or protocol issues
THEN Risk Impact MAY RESULT Subject safety, rights, and/or well-being might be impacted and/or data integrity might be affected, leading to the inability to use subject data.
Risk Indicator High Level of Protocol Deviations (PDs)
Metric Protocol Deviations per Subject Visit
Unit PD per visit
What level should be measured Study, Country, Site
Purpose Monitor adherence to study protocols, maintain data integrity, and uphold ethical and regulatory standards in clinical trials or research studies.
Description This KRI monitors the level of protocol deviations (PDs) occurring in clinical trials or research studies. It triggers an alert if that level is too high.
Formula (Number of Protocol Deviations) / (Number of Subject Visits). Use values from the same date. Count only scheduled visits.
Suggested Thresholds - High 1 PD per visit
Suggested Thresholds - Medium 0.7 PD per visit
Associated Metric 1 Number of Protocol Deviations
Associated Metric 2 Number of Subject Visits (Scheduled)
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