Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Was the actual date of birth recorded in IWRS?
Item
Was the actual date of birth recorded in IWRS?
boolean
C0421451 (UMLS CUI [1])
Date of informed consent
Item
Subject signed informed consent on
date
C2985782 (UMLS CUI [1])
Consent to sampling for DNA research
Item
Did the subject consent to sampling for DNA research?
boolean
C0021430 (UMLS CUI [1,1])
C0444245 (UMLS CUI [1,2])
Consent to long term storage and exploratory analysis of blood samples
Item
Did the subject consent to long term storage and exploratory analysis of blood samples as described in the ICF?
boolean
C0021430 (UMLS CUI [1,1])
C1698986 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,4])
C0936012 (UMLS CUI [1,5])
Item
Sex at birth
integer
C0079399 (UMLS CUI [1,1])
C2599577 (UMLS CUI [1,2])
Childbearing potential
Item
If female, is this a female of childbearing potential?
boolean
C3831118 (UMLS CUI [1])
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
CL Item
not allowed to ask per local regulations (1)
CL Item
hispanic or latino (2)
CL Item
not hispanic or not latino (3)
Item
Race
integer
C0034510 (UMLS CUI [1])
CL Item
not allowed to ask per local regulations (1)
CL Item
American Indian or Alaska Native (2)
CL Item
Black or African American (4)
CL Item
Native Hawaiian or Other Pacific Islander (5)
Item
Does the subject smoke?
integer
C1519386 (UMLS CUI [1])
Code List
Does the subject smoke?
Alcohol consumption
Item
Does the subject drink alcohol? If yes, please state the number of units/week where applicable
boolean
C0001948 (UMLS CUI [1])
Beer consumption
Item
Beer consumption
text
C2107808 (UMLS CUI [1])
Wine consumption
Item
Wine consumption
text
C2203276 (UMLS CUI [1])
Distilled spirits consumption
Item
Distilled spirits consumption
text
Drug abuse
Item
Does the subject use recreational drugs?
boolean
C0013146 (UMLS CUI [1])
Amphetamine
Item
Amphetamine
boolean
C0002667 (UMLS CUI [1])
Barbiturates
Item
Barbiturates
boolean
C0004745 (UMLS CUI [1])
Benzodiazepines
Item
Benzodiazepines
boolean
C0005064 (UMLS CUI [1])
Cocaine
Item
Cocaine
boolean
C0009170 (UMLS CUI [1])
Cannabinoids
Item
Cannabinoids
boolean
C0006864 (UMLS CUI [1])
Opioids
Item
Opioids
boolean
C0242402 (UMLS CUI [1])
Previous participation in a trial
Item
Has the subject previously participated in a Tibotec sponsored trial?
boolean
C2348568 (UMLS CUI [1])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Site ID
Item
Site ID
text
C2826692 (UMLS CUI [1])
Country code
Item
Country code
text
C0805701 (UMLS CUI [1,1])
C0454664 (UMLS CUI [1,2])