Englisch

Informed Consent, Demographics, Randomisation

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Cohort
Beschreibung

Cohort

Datentyp

integer

Alias
UMLS CUI [1]
C0599755
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Informed Consent
Beschreibung

Informed Consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Beschreibung

Informed Consent Date

Datentyp

date

Alias
UMLS CUI [1]
C2985782
Did the parents/guardians agree that the biological samples(s) of their child/ward may be used by GSK Biologicals for further research that is NOT RELATED to the vaccine(s) or the disease(s) under study?
Beschreibung

Agreed that biological samples be used for research not related to this study

Datentyp

text

Alias
UMLS CUI [1,1]
C3641827
UMLS CUI [1,2]
C2347026
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0035168
Did the parents/guardians agree that the biological samples of their child/ward may be used for HIV testing?
Beschreibung

Agreed that biological samples may be used for HIV testing

Datentyp

text

Alias
UMLS CUI [1,1]
C3641827
UMLS CUI [1,2]
C2347026
UMLS CUI [1,3]
C1321876
Demographics
Beschreibung

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Beschreibung

Center number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beschreibung

Ethnicity

Datentyp

integer

Alias
UMLS CUI [1]
C0015031
Race
Beschreibung

Race

Datentyp

integer

Alias
UMLS CUI [1]
C0034510
African Heritage / African American race specification
Beschreibung

African Heritage / African American race specification

Datentyp

text

Alias
UMLS CUI [1,1]
C0085756
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C0027567
UMLS CUI [2,2]
C2348235
If other race, please specify
Beschreibung

Other race specification

Datentyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0034510
UMLS CUI [1,3]
C2348235
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Randomisation/ Treatment Allocation
Beschreibung

Randomisation/ Treatment Allocation

Alias
UMLS CUI-1
C0034656
Record treatment number
Beschreibung

Treatment Number

Datentyp

integer

Alias
UMLS CUI [1]
C1522541
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Ähnliche Modelle

Informed Consent, Demographics, Randomisation

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
HIV-pos. (1)
CL Item
HIV-neg. exposed (2)
CL Item
HIV-neg. unexposed, 3+1 schedule (3)
CL Item
HIV-neg. unexposed, 3+0 schedule (4)
CL Item
HIV-neg. unexposed, 2+1 schedule (5)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Item
Did the parents/guardians agree that the biological samples(s) of their child/ward may be used by GSK Biologicals for further research that is NOT RELATED to the vaccine(s) or the disease(s) under study?
text
C3641827 (UMLS CUI [1,1])
C2347026 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0035168 (UMLS CUI [1,4])
Agreed that biological samples be used for research not related to this study
Code List
Did the parents/guardians agree that the biological samples(s) of their child/ward may be used by GSK Biologicals for further research that is NOT RELATED to the vaccine(s) or the disease(s) under study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
not applicable (NA)
Item
Did the parents/guardians agree that the biological samples of their child/ward may be used for HIV testing?
text
C3641827 (UMLS CUI [1,1])
C2347026 (UMLS CUI [1,2])
C1321876 (UMLS CUI [1,3])
Agreed that biological samples may be used for HIV testing
Code List
Did the parents/guardians agree that the biological samples of their child/ward may be used for HIV testing?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
not applicable (NA)
Item Group
Demographics
C1704791 (UMLS CUI-1)
Center number
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
American Hispanic or Latino (1)
CL Item
Not American Hispanic or Latino (2)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
African Heritage / African American, specify below (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic / North African Heritage (8)
CL Item
White - Caucasian / European Heritage (9)
CL Item
Other, specify below (99)
African Heritage / African American race specification
Item
African Heritage / African American race specification
text
C0085756 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0027567 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Other race specification
Item
If other race, please specify
text
C0205394 (UMLS CUI [1,1])
C0034510 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Randomisation/ Treatment Allocation
C0034656 (UMLS CUI-1)
Treatment Number
Item
Record treatment number
integer
C1522541 (UMLS CUI [1])
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