Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Site
Item
Study Site
text
Subject
Item
Subject
text
CL Item
Period 2 Day 18 + Day 19 + Day 20 (1)
CL Item
Visit 240+250+260 (1)
Document Number
Item
Document Number
integer
Visit Date
Item
Visit Date
date
Item Group
Vital Signs - Duplicate 1
Time of Vital Signs
Item
Time of Vital Signs
time
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
Heart Rate
Item
Heart Rate
integer
Temperature
Item
Temperature
float
Body Position
Item
Body Position
text
Comment
Item
Comment
text
Item Group
Vital Signs - Duplicate 2
Time of Vital Signs
Item
Time of Vital Signs
time
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
Heart Rate
Item
Heart Rate
integer
Body Position
Item
Body Position
text
Comment
Item
Comment
text
Item Group
Study Drug Administration
dose administered?
Item
Was the dose administered?
boolean
Dose Date
Item
Dose Date
date
Dose Time
Item
Dose Time
time
Comment
Item
Comment
text
Visit Date
Item
Visit Date
date
Item Group
Vital Signs - Duplicate 1
Time of Vital Signs
Item
Time of Vital Signs
time
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
Heart Rate
Item
Heart Rate
integer
Temperature
Item
Temperature
float
Body Position
Item
Body Position
text
Comment
Item
Comment
text
Item Group
Vital Signs - Duplicate 2
Time of Vital Signs
Item
Time of Vital Signs
time
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
Heart Rate
Item
Heart Rate
integer
Body Position
Item
Body Position
text
Comment
Item
Comment
text
Item Group
Study Drug Administration
Was the dose administered?
Item
Was the dose administered?
boolean
Dose Date
Item
Dose Date
date
Dose Time
Item
Dose Time
time
Comment
Item
Comment
text
Item Group
Study Drug Administration 2
Was the dose administered?
Item
Was the dose administered?
boolean
Dose Date
Item
Dose Date
date
Dose Time
Item
Dose Time
time
Item
Site of Injection
text
Code List
Site of Injection
CL Item
Right Abdomen (1)
Comment
Item
Comment
text
Item Group
Pharmacokinetic Blood Collection
not done / not collected?
Item
Was the sample collected? / Was the test done?
boolean
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text
Visit Date
Item
Visit Date
date
Item Group
Vital Signs - Duplicate 1
Time of Vital Signs
Item
Time of Vital Signs
time
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
Heart Rate
Item
Heart Rate
integer
Temperature
Item
Temperature
float
Body Position
Item
Body Position
text
Comment
Item
Comment
text
Item Group
Vital Signs - Duplicate 2
Time of Vital Signs
Item
Time of Vital Signs
time
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
Heart Rate
Item
Heart Rate
integer
Body Position
Item
Body Position
text
Comment
Item
Comment
text
Item Group
Electrocardiogram
Date of ECG performed
Item
Date of ECG performed
date
Time of ECG performed
Item
Time of ECG performed
time
Heart Rate
Item
Heart Rate
integer
PR Interval
Item
PR Interval
float
QRS Duration
Item
QRS Duration
float
QT Interval
Item
QT Interval
float
QTcB Interval
Item
QTcB Interval
float
QTcF Interval
Item
QTcF Interval
float
RR Interval
Item
RR Interval
float
Normal Sinus Rhythm?
Item
Normal Sinus Rhythm?
boolean
Item Group
Overall Interpretation of ECG
Item
Check one ECG interpretation result
text
Code List
Check one ECG interpretation result
CL Item
Abnormal; Not clinically significant (2)
CL Item
Abnormal; Clinically significant (3)
If abnormal, please specify
Item
If abnormal, please specify
text
Item Group
Study Drug Administration
dose administered?
Item
Was the dose administered?
boolean
Dose Date
Item
Dose Date
date
Dose Time
Item
Dose Time
time
Comment
Item
Comment
text
Item Group
Hematologic Test
Was the laboratory sample collected?
Item
Was the laboratory sample collected?
boolean
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text
Item Group
Chemistry Test
Was the laboratory sample collected?
Item
Was the laboratory sample collected?
boolean
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text
Item Group
UA/Urine Chemistry
sample collected?
Item
Was the laboratory sample collected?
boolean
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text
Item Group
Pharmacokinetic Blood Collection
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
not done/not colected
Item
Was the sample collected? / Was the test done?
boolean
Comment
Item
Comment
text