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Example Case Report Forms for EC domain


Form: Exposure-Infusion

Question Response
Start Date
Start Time
Stop Date
Stop Time
Was the entire infusion administered?

If No, provide Reason for Stopping Current Infusion

If 'Other', specify
Total Volume Prepared
Total Volume Prepared Unit
Actual Volume Infused
Actual Volume Infused Unit

Form: Study Drug Administration

Question Response
Dosing Date
Dosing Time
Quantity Administered
Quantity Units
Concentration of preparation

Reason for dose adjustment