Informed Consent
Admission Criteria
Failed Eligibility Criteria
If the subject did not meet all eligibility criteria, please specify criteria number and explain below
integer
Check One Criteria Type
integer
Waiver Granted?
boolean
Date of Sponsor Approval
date
Comment
text
Demographics
Race
Check all that apply
integer
If Other, please specify
text
Potentially Childbearing
Electrocardiogram
Date ECG performed
date
Time ECG performed
time
Heart Rate
integer
PR Interval
integer
QRS Duration
float
QT Interval
float
QTcB Interval
float
QTcF Interval
float
RR Interval
float
Normal sinus rhythm?
boolean
Overall interpretation of ECG
Hematology Test
Chemistry / Serum HCG / SP Chemistry
Was the laboratory sample collected?
boolean
Sample Date
date
Sample Time
time
Comment
text
Pregnancy test result
text
UA / UDS / Urine Chemistry
Serology