Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Subject
Item
Subject
text
CL Item
Period 1 Day 1 (1)
blank page?
Item
Is Page Blank?
boolean
Visit Date
Item
Visit Date
date
Item Group
Admission Criteria
Protocol Date
Item
Protocol Date
date
Does the subject continue to meet all eligibility criteria?
Item
Does the subject continue to meet all eligibility criteria?
boolean
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
Laboratory Test - Hematology
Was laboratory sample collected?
Item
Was laboratory sample collected?
boolean
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text
Item Group
Laboratory Test - Chemistry
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
Laboratory Test - UA / UDS / Urine HCG / Urine Chemistry
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
Date of Vital Signs
Item
Date of Vital Signs
date
Item
Duplicate Number
integer
Code List
Duplicate Number
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
Pharmacodynamic Blood Collection
Was the sample collected?
Item
Was the sample collected?
boolean
CL Item
Progesterone (SP Chem) (1)
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text
Item Group
Pharmacodynamic Blood Collection
Was the sample collected?
Item
Was the sample collected?
boolean
CL Item
LH / FSH (SP Chemistry) (1)
Sample Date
Item
Sample Date
time
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text