Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study Site; Numbers
Item
Site number
text
C2825164 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Person Initials
Item
Patient's initials
text
C2986440 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Patient's trial number
text
C2348585 (UMLS CUI [1])
Item Group
Date of Examination (Vital Signs/ Weight, Physical Examination)
C2826643 (UMLS CUI-1)
Physical Examination Date
Item
Date of Examination (Vital Signs/ Weight, Physical Examination)
date
C2826643 (UMLS CUI [1])
Item Group
Vital Signs/ Weight
C0518766 (UMLS CUI-1)
C0005910 (UMLS CUI-3)
Blood Pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
Pulse Rate
Item
Pulse rate
integer
C0232117 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Item
Body region/ system
integer
C0460002 (UMLS CUI [1])
Code List
Body region/ system
CL Item
Ears, nose, throat (2)
CL Item
Cardiovascular (3)
CL Item
Musculoskeletal (9)
CL Item
Other, specify (10)
body system; Other; Specification
Item
If other body region/ system, specify
text
C0460002 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Finding
integer
C0243095 (UMLS CUI [1])
CL Item
Not examinated (3)
Physical Examination Abnormal Finding
Item
Abnormal physical finding
text
C2826636 (UMLS CUI [1])
Item Group
Neurological Examination - Date and Finding
C0027853 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
C0437208 (UMLS CUI-3)
Neurologic Examination; Date in time
Item
Date of examination
date
C0027853 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Exam- either normal OR abnormalities present
integer
C1112287 (UMLS CUI [1])
C0437208 (UMLS CUI [2])
Code List
Exam- either normal OR abnormalities present
CL Item
Abnormalities present (2)
Item Group
Neurological Examination abnormalities - Mental status
C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0278060 (UMLS CUI-3)
Item
Mental status abnormalities
integer
C1704258 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
Code List
Mental status abnormalities
CL Item
Decreased attention (e.g. decreased consentration, poor/ short attention span) (1)
CL Item
Psychomotor slowing or retardation (developmental delay) (2)
CL Item
Somnolence (e.g. sedation, drowsiness, lethargy, sleepiness) (3)
CL Item
Depressed affect (4)
CL Item
Inapropriate affect (5)
CL Item
Hyperactivity (6)
CL Item
Behavioral discontrol (7)
CL Item
Other, specify (8)
Abnormality; Mental state; Other; Specification
Item
If other abnormal mental status, specify.
text
C1704258 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Check if abnormal mental status.
integer
C1704258 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
Code List
Check if abnormal mental status.
Item
Intensity of abnormality (mental status)
integer
C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0278060 (UMLS CUI [2])
Code List
Intensity of abnormality (mental status)
Item Group
Neurological Examination abnormalities - Speech/ language
C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0564649 (UMLS CUI-3)
Item
Speech/ language abnormalities
integer
C0037822 (UMLS CUI [1])
C0023008 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
Code List
Speech/ language abnormalities
CL Item
Dysphasia or aphasia (2)
Item
Check if abnormal Speech/ language.
integer
C1704258 (UMLS CUI [1,1])
C0037817 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0023008 (UMLS CUI [2,2])
Code List
Check if abnormal Speech/ language.
Item
Intensity of abnormality (speech/ language)
integer
C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0037817 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C0439793 (UMLS CUI [2,2])
C0023008 (UMLS CUI [2,3])
Code List
Intensity of abnormality (speech/ language)
Item Group
Neurological Examination abnormalities - Cranial nerves
C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0010268 (UMLS CUI-4)
Item
Cranial nerves abnormalities
integer
C0010268 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Code List
Cranial nerves abnormalities
CL Item
Nystagmus on lateral gaze (horizontal) (1)
CL Item
Other, specify (2)
Item
Check if abnormal cranial nerves.
integer
C1704258 (UMLS CUI [1,1])
C0010268 (UMLS CUI [1,2])
Code List
Check if abnormal cranial nerves.
Item
Intensity of abnormality (cranial nerves)
integer
C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0010268 (UMLS CUI [1,3])
Code List
Intensity of abnormality (cranial nerves)
Abnormality; Cranial Nerves; Other; Specification
Item
If other abnormality of cranial nerves, specify.
text
C1704258 (UMLS CUI [1,1])
C0010268 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Neurological Examination abnormalities - Gait
C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0016928 (UMLS CUI-3)
Item
Gait abnormalities
integer
C0016928 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Code List
Gait abnormalities
CL Item
Hemiplegic gait (2)
CL Item
Spasticity, bilateral (3)
CL Item
Other gait disturbance (4)
Item
Check if abnormal gait.
integer
C1704258 (UMLS CUI [1,1])
C0016928 (UMLS CUI [1,2])
Code List
Check if abnormal gait.
Item
Intensity of abnormality (gait)
integer
C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0016928 (UMLS CUI [1,3])
Code List
Intensity of abnormality (gait)
Item Group
Neurological Examination abnormalities - Coordination
C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0242414 (UMLS CUI-3)
Item
Coordination abnormalities
integer
C0242414 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Code List
Coordination abnormalities
CL Item
Resting tremor (1)
CL Item
Intention tremor (2)
CL Item
Postural tremor (3)
CL Item
Dysdiadochokinesia (on rapid alt. movements) (4)
Item
Check if abnormal coordination.
integer
C1704258 (UMLS CUI [1,1])
C0242414 (UMLS CUI [1,2])
Code List
Check if abnormal coordination.
Item
Intensity of abnormality (coordination)
integer
C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0242414 (UMLS CUI [1,3])
Code List
Intensity of abnormality (coordination)
Item Group
Neurological Examination abnormalities - Sensation
C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0036658 (UMLS CUI-3)
Item
Sensation abnormalities
integer
C0036658 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Code List
Sensation abnormalities
CL Item
Romberg positive (5)
Item
Check if abnormal sensation.
integer
C1704258 (UMLS CUI [1,1])
C0036658 (UMLS CUI [1,2])
Code List
Check if abnormal sensation.
Item
Intensity of abnormality (sensation)
integer
C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0036658 (UMLS CUI [1,3])
Code List
Intensity of abnormality (sensation)
Item Group
Neurological Examination abnormalities - Muscle strength
C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0517349 (UMLS CUI-3)
Item
Muscle strength abnormalities
integer
C0517349 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Code List
Muscle strength abnormalities
CL Item
Decreased muscle strength (1)
Item
Check if abnormal muscle strength.
integer
C1704258 (UMLS CUI [1,1])
C0517349 (UMLS CUI [1,2])
Code List
Check if abnormal muscle strength.
Item
Intensity of abnormality (muscle strength)
integer
C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0517349 (UMLS CUI [1,3])
Code List
Intensity of abnormality (muscle strength)
Item Group
Neurological Examination abnormalities - Muscle tone
C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0026841 (UMLS CUI-3)
Item
Muscle tone abnormalities
integer
C0026841 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Code List
Muscle tone abnormalities
Item
Check if abnormal muscle tone.
integer
C1704258 (UMLS CUI [1,1])
C0026841 (UMLS CUI [1,2])
Code List
Check if abnormal muscle tone.
Item
Intensity of abnormality (muscle tone)
integer
C1704258 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
C0026841 (UMLS CUI [1,3])
Code List
Intensity of abnormality (muscle tone)
Item Group
Neurological Examination abnormalities - Reflexes
C0027853 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C0034929 (UMLS CUI-3)
Item
Reflexes abnormalities
integer
C0034929 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Code List
Reflexes abnormalities
CL Item
Brachioradialis left (3)
CL Item
Brachioradialis right (4)
CL Item
Plantar response left (9)
CL Item
Plantar response right (10)
Item
Check if abnormal reflexes.
integer
C1704258 (UMLS CUI [1,1])
C0034929 (UMLS CUI [1,2])
Code List
Check if abnormal reflexes.
Item
Type of abnormality (reflexes)
integer
C1704258 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0034929 (UMLS CUI [1,3])
Code List
Type of abnormality (reflexes)
Item Group
Electroencephalogram
C0013819 (UMLS CUI-1)
Assessment Date
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Item Group
Electrocardiogram
C1623258 (UMLS CUI-1)
Electrocardiogram Date
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
electrocardiogram: ventricular rate
Item
Ventricular rate
integer
C2189285 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR interval
float
C0429087 (UMLS CUI [1])
QT interval - finding
Item
QT
float
C1287082 (UMLS CUI [1])
RR interval
Item
RR
float
C0489636 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS duration
float
C0429025 (UMLS CUI [1])
Item
ECG EITHER normal OR normal variants present/ Abnormalities present
integer
C0522054 (UMLS CUI [1])
C1623258 (UMLS CUI [2,1])
C0205419 (UMLS CUI [2,2])
C0205307 (UMLS CUI [2,3])
C0522055 (UMLS CUI [3])
Code List
ECG EITHER normal OR normal variants present/ Abnormalities present
CL Item
Normal variants present (comment below) (2)
CL Item
Abnormalities present (check abnormalities below) (3)
Item
A. Rhythm
integer
C0232187 (UMLS CUI [1])
CL Item
Sinus brachycarida (1)
CL Item
Sinus tachycardia (2)
CL Item
Ectopic supraventricular beats (4)
CL Item
Junctional rhythm (5)
CL Item
Supraventricular tachycardia (6)
CL Item
Atrial flutter (7)
CL Item
Atrial fibrillation (8)
CL Item
Ectopic ventricular beats (9)
CL Item
Ventricular escape rhythm (10)
CL Item
Ventricular tachycardia (11)
Item
B. Conduction
integer
C0232217 (UMLS CUI [1])
CL Item
First degree AV block (1)
CL Item
Second degree AV block (Mobitz type 1) (2)
CL Item
Second degree AV block (Mobitz type 2) (3)
CL Item
Third degree AV block (4)
CL Item
Left axis deviation (5)
CL Item
Right axis deviation (6)
CL Item
Right bundle branch block (7)
CL Item
Left bundle branch block (8)
CL Item
Nonspecific intraventricular conduction delay (9)
CL Item
Accessory pathway (Wolff- Parkinson- White) (10)
CL Item
QTc prolongation (11)
Item
C. Depolarization/ Repolarization (QRS-T)
integer
C1331539 (UMLS CUI [1])
C3279217 (UMLS CUI [2])
Code List
C. Depolarization/ Repolarization (QRS-T)
CL Item
Myocardial infarction, old (1)
CL Item
Myocardial infarction, other- comment (2)
CL Item
Non- specific ST-T changes (3)
CL Item
Low QRS voltage (4)
Item
Other ECG findings
integer
C0438154 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Code List
Other ECG findings
Electrocardiogram finding; Other; Specification
Item
If other ECG finding, specify.
text
C0438154 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Electrocardiography; Comment | Electrocardiography; Conclusion
Item
Comments/ Conclusion (ECG)
text
C1623258 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2,1])
C1707478 (UMLS CUI [2,2])