Electronically transferred laboratory data Day 1
Clinical chemistry
datetime
Haematology
datetime
Urinalisys
datetime
Blood
datetime
Blood sample number
text
Vital signs Day 1
Date
date
Planned relative time
integer
Actual time
integer
Supine mmHg
text
Systolic Blood Pressure
integer
Diastolic blood pressure
integer
Heart rate
integer
Temperature
text
12-Lead-ECG
Start date of ECG
date
Planned Relative Time
time
Start Time of ECG
time
Ventricular Rate
integer
PR Interval
integer
QRS Duration
integer
Uncorrected QT Interval
integer
QTc Invertal
integer
1 = Machine 2 = Manual For Machine reads QTcB Interval, and/or QTcF can be collected
text
QTcB Interval
integer
QTcF Interval
integer
QTc Interval unknown method of correction
integer
Enter code for result from the following list: 1=Normal 2=Abnormal - not clinically significant 3=Abnormal - clinically significant 4=No result (not available)
integer
12 LEAD ECG Day 1
ECG number
integer
ECG 1
integer
Start date of ECG
text
Planned Relative Time
text
Start Time of ECG
time
Heart rate
integer
PR Interval
integer
QRS Duration
integer
QRS Duration
integer
Uncorrected QT Interval
integer
1 = Machine 2 = Manual For Machine reads QTcB Interval, and/or QTcF can be collected
text
QTcB Interval
integer
QTcF Interval
integer
QTc Interval unknown method of correction
integer
enter code for result from the following list: 1=normal, 2=abnormal-not clinically significant, 3=abnormal-clinically significant, 4= no result (not available)
integer
12 LEAD ECG Abnormalities Day 1
Date of ECG
date
Time of ECG
time
Rhythm
text
P-Wave and QRS Morphology
text
Conduction
text
Myocardial Infraction
text
Depolarisation/Repolarisation (QRS-T)
text
Other abnormalities
text
Treatment details
record randomisation number
integer
Investigational product Day 1
text
e.g. 5 JUN 08
date
e.g 10:54
time
Actual dose
integer
Units
integer
PO
text
SOL
text
Did the subject receive the correct treatment (e.g., treatment that the subject was assigned to) during this dosing interval
text
If "No" record reasons
text
Pharmacokinetics Day 1
Blood - Day1
text
time relative to dosing
integer
Date sample taken
date
Actual time
time
Sample number
integer
Blood - Metabolite samples
text
time relative to dosing
text
Date sample taken
date
Actual time
time
Sample number
integer
Urine
text
Pharmacokinetic Sampling Urine Interval Collection Data - Day 1
text
time relative to dosing
text
Start date
date
Actual start time
time
Stop date
date
Actual stop time
time
Toltal sample weight
float
Sample number
text
Faeces
text
Pharmacokintec sampling faeces interval collection data - Day1
text
time relative to dosing
text
Start Date
date
Actual start time
time
Stop Date
date
Actual stop time
time
Total sample weight
float
Sample number
text
2 hrs - 6.5 hrs post-dose
text
time relative to dosing
text
Procedure
text
e.g., 01 JAN 10
date
e.g, 10:35
time
16:35
time