12-LEAD ECG
day month year
date
Three measurements, at least 2 minutes apart, will be taken at each specified time – the subject having rested in the supine position for at least 5 minutes before the first measurement. The mean of the three scheduled values recorded immediately pre-dose will be defined as baseline.
integer
00:00-23:59
time
Ventricular Rate
integer
PR Interval
integer
QRS Duration
integer
Uncorrected QT Interval
integer
QTc Interval
integer
QTc (F)
integer
If a subject’s QTcF interval extends beyond 500msec or is increased more than 60msec compared to baseline (confirmed on three or more ECG tracings separated by at least 2 minutes), the ECG tracing should be examined by an appropriately trained physician and manual measurements undertaken. If the reading is confirmed, the subject should be closely monitored and followed in the clinical unit until the QT and QTc(F) interval return to within 30msec of their baseline.
integer
enter code for result from the following list. If you tick Abnormal-clinically significant: Complete the Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for a SAE. Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.
integer