Visit date
Vital signs
Date
date
Planned Relative Time
text
Planned Absolute time
integer
Actual time
time
Systolic Blood Pressure
integer
Diastolic Blood Pressure
integer
Subject position
text
Heart Rate
integer
12-Lead-ECG
Start date of ECG
date
Planned Relative Time
text
Start Time of ECG
time
Ventricular Rate
integer
PR Interval
integer
QRS Duration
integer
Uncorrected QT Interval
integer
QTc Invertal
integer
Enter code for result from the following list: 1=Normal 2=Abnormal - not clinically significant 3=Abnormal - clinically significant 4=No result (not available)
integer
Investigational Product
Planned timepoint
text
Date of dose
date
Time of dose
time
Treatment Confirmation
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
text
If No, record reason(s)
text