Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
Site
Item
Study Site
text
Subject
Item
Subject
text
CL Item
Period 2 Day 13+ Day 14 (1)
CL Item
Visit 220+230 (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
Item Group
Pharmacodynamic Blood Collection
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
Electrocardiogram
ECG date
Item
Date of ECG performed
date
ECG time
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 option
text
Code List
Check one option
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
Pharmacodynamic Blood Collection
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
