High Percentage of High Risk Sites in a Study Table
High Percentage of High Risk Sites in a Study
Type of indicator
Performance
Risk Category
Organizational experience
Golden KRI
No
Therapeutic Area
General
IF Risk-Event
The inclusion of the higher risk sites occurs
DUE TO Risk Causes
A lack of experience, the sponsor's desire despite previous warnings or need of budget hospitals
THEN Risk Impact MAY RESULT
Non-compliance with timelines, budget and data quality
Risk Indicator
High Percentage of High Risk Sites in a Study
Metric
Percent of high risk sites
Unit
%
What level should be measured
Study, Country
Comments
The KRI requires information of Site risk assessment from the previous studies.
Purpose
Ensure the overall success of the study by identifying and managing high-risk sites, mitigating potential risks, and optimizing data quality and participant safety.
Description
KRI monitors the proportion of sites classified as high-risk within a study, ensuring proactive management of potential challenges and risks to data quality and participant safety.
Formula
Divide the number of high risk sites by the total number of initiated sites, multiply by 100%
Suggested Thresholds - High
>20 %
Suggested Thresholds - Medium
>15 %
Associated Metric 1
Number of Initiated Sites
Associated Metric 2
Number of High Risk Sites
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