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 resource, improper delegation, inadequate training, protocol issues
THEN Risk Impact MAY RESULT	Participant safety, rights and/or well-being might be impacted and/or data integrity might be affected leading to inability to use participant data.
Risk Indicator	High level of protocol deviations (PDs)
Metric	Protocol deviations per participant 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 alarms if that level is too high.
Formula	(Number of Protocol Deviations)/(Number of Subjects Visits). Use values from the same date.
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