Did the subject meet all Eligibility Criteria?
Item
Did the subject meet all Eligibility Criteria?
boolean
C0013893 (UMLS CUI [1])
List all Inclusion criteria subject did not meet
Item
List all Inclusion criteria subject did not meet
integer
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
List all Exclusion criteria subject did not meet
Item
List all Exclusion criteria subject did not meet
integer
C0680251 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Was an Exemption granted?
Item
Was an Exemption granted?
boolean
C1516637 (UMLS CUI [1,1])
C2348482 (UMLS CUI [1,2])
Was a physical examination performed?
Item
Was a physical examination performed?
boolean
C0031809 (UMLS CUI [1])
Date of Physical Examination
Item
Date of Physical Examination
date
C2826643 (UMLS CUI [1])
Item
Clinical Assessment
integer
C4534461 (UMLS CUI [1])
Code List
Clinical Assessment
CL Item
General Appearance (1)
CL Item
Musculoskeletal (2)
CL Item
Skin and Mucosa (3)
CL Item
Head and Neck (4)
CL Item
Gastrointestinal (8)
CL Item
Cardiovascular (9)
CL Item
Neurological (11)
CL Item
Psychological (12)
CL Item
Genitourinary (13)
CL Item
Eyes,ears,nose & throat (15)
CL Item
Other (specify) (99)
If other Clinical Assessment, please specify
Item
If other Clinical Assessment, please specify.
text
C4534461 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Physical Findings
integer
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Code List
Physical Findings
Please specify Abnormal conditions
Item
Please specify Abnormal conditions
text
C0348080 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Were vital signs assessed?
Item
Were vital signs assessed?
boolean
C0518766 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Item
Position
integer
C1262869 (UMLS CUI [1])
Systolic BP
Item
Systolic BP
integer
C0871470 (UMLS CUI [1])
Diastolic BP
Item
Diastolic BP
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Respiration Rate
Item
Respiration Rate
integer
C0231832 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Temperature Unit
integer
C0005903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Temperature Unit
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Item
Height Unit
integer
C0005890 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
Weight Unit
integer
C0005910 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Is the subject female of child-bearing potential?
Item
Is the subject female of child-bearing potential?
boolean
C1960468 (UMLS CUI [1])
Has a serum β-hCG pregnancy test been performed?
Item
Has a serum β-hCG pregnancy test been performed?
boolean
C0430060 (UMLS CUI [1])
Date of pregnancy test
Item
Date of pregnancy test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result of pregnancy test
integer
C0427777 (UMLS CUI [1])
Code List
Result of pregnancy test
Date of Sampling
Item
Date of Sampling
date
C0870078 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Sampling
Item
Time of Sampling
time
C0870078 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Check if Not Done
integer
C1272696 (UMLS CUI [1])
Code List
Check if Not Done
Was SRT501 administered at this visit?
Item
Was SRT501 administered at this visit?
boolean
C0304229 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
Date administered
Item
Date administered
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Kit #
Item
Kit #
integer
C2981406 (UMLS CUI [1])
Time administered
Item
Time administered
time
C1533734 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])