Vital signs
Height
integer
Weight
float
Body mass index
integer
Day Month Year e.g., 01 JAN 08
text
e.g., 15 min
text
HR : MN (00:00 - 23:59) e.g., 13:02
text
Supine mmHg Systolic Diastolic e.g.,110 80
text
beats/min e.g., 75
text
°C e.g., 36.5
float
12-lead ECG
ECG Number
integer
Day Month Year
date
Planned Relative Time ECG
text
Start Time of ECG
time
Heart Rate
integer
PR Interval
float
QRS Duration
float
Uncorrected QT Interval
float
1=Machine, 2=Manual For machine read ECGs, QTcB and/or QTcF can be collected.
integer
If machine, QTcB interval
integer
If machine, QTcF interval
integer
If machine, QTc interval unknown method of correction
integer
Result of the ECG
integer
Important
text
12-Lead ECG Abnormalities
A. Rhythm
text
B. P-Wave and QRS Morphology
integer
C. Conduction
integer
D. Myocardial Infraction
integer
E. Depolarisation/Repolarisation (QRS-T)
integer
Other abnormalities
integer
Date of ECG
date
Time of ECG
time
Summary Holter (12HRS)
Holter Results
text
Start date of Holter
date
Start time of Holter
time
Stop time of Holter
time
Interpretation of Holter tick one
text
Holter monitoring method tick one
text
Summary Holter Abnormalities
tick all that apply
text
Medical conditions
Physical Examination
Date of Assessment
date
Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely: [different findings should be separated by either a (;) or a (/)].
text
1. Head
text
2. Eyes
text
3. Ears
text
4. Nose
text
5. Throat
text
6. Skin
text
7. Thyroid
text
8. Neurological
text
9. Lungs
text
10. Cardiovascular
text
11. Abdomen (Liver and Spleen)
text
12. Lymph Nodes
text
13. Extremities
text
Alcohol and Tobacco Use
What is the subject's history of smoking use?
text
When did the subject last smoke?
date
If former smoker, answer the following:
text
Date sample taken
date
Does the subject consume alcohol?
text
if Yes, do the following
float
Date and time of sample taken
datetime
Electronically transferred laboratory data
Pharmacokinetics
Inclusion and exclusion criteria
Eligibility question
text
tick the boxes corresponding to any of the inclusion criteria the subject failed.
text
tick the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
text