Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Study Name
Item
Study Name
text
Subject
Item
Subject
text
CL Item
Period 1 Day 20 (1)
Document #
Item
Document #
text
Visit Date
Item
Visit Date
date
Date of Vital Signs
Item
Date of Vital Signs
date
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
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
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
Hematology Test
Was the laboratory sample collected?
Item
Was the laboratory sample collected?
boolean
Sample Date
Item
Sample Date
date
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 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
Pharmacokinetic Blood Collection
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
sample collected?
Item
Was the sample collected?
boolean
Comment
Item
Comment
text
Item Group
Period 1 - Day 21
Date of Visit
Item
Date of Visit
date
Date of Vital Signs
Item
Date of Vital Signs
date
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
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 ECG Performed
Item
Date ECG Performed
date
Time ECG performed
Item
Time 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 the result interpretation
text
Code List
Check the result interpretation
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
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
Pharmacodynamic Blood Connection
CL Item
Progesterone (SP Chem) (1)
Date sample taken
Item
Date sample taken
date
Time sample taken
Item
Time sample taken
time
Was the sample collected?
Item
Was the sample collected?
boolean
Comment
Item
Comment
text
Item Group
Pharmacokinetic Blood Collection 12 hr span
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Was the sample collected / Was the test done?
Item
Was the sample collected / Was the test done?
boolean
Comment
Item
Comment
text