Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Subject
Item
Subject
text
CL Item
Period 2 Day 1 (1)
Document #
Item
Document #
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
integer
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
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
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text
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 / UDS / Urine HCG / 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
Pharmacodynamic Blood Collection
CL Item
Progesterone (SP Chem) (1)
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
Item Group
Pharmacodynamic Blood Collection 2
CL Item
LH / FSH (SP Chem) (1)
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
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
Study Drug Administration 2
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
