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10.6.2
Vital Signs - Coggle Diagram
10.6.2
Vital Signs
Integration
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Missing
By Subject
Vital Sign test is not done, but without 'not done’ record
By Site
Vital Sign test is not done, but without 'not done’ record
Outlier
By Subject
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For screening vistal signs, significant outlier against protocol in/ex criteria
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By Site
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For screening vistal signs, significant outlier against protocol in/ex criteria
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Trends
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Data Variability
Cross Country
Potential suspect data case 1:
Value keep stable, lack of change by visit/cycle
Potential suspect data case 2:
Value change in fixed rule (such as increasing or decreasing in multiple times)
Cross Site
Potential suspect data case 1:
Value keep stable, lack of change by visit/cycle
Potential suspect data case 2:
Value change in fixed rule (such as increasing or decreasing in multiple times)
Cross Subject
Potential suspect data case 1:
Value keep stable, lack of change by visit/cycle
Potential suspect data case 2:
Value change in fixed rule (such as increasing or decreasing in multiple times)