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Visit 1: Eligibility Criteria

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Eligibility Check
Description

Eligibility Check

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Description

If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1550543
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Completion of Visit 7, Month 21 of Malaria-026
Description

Completion of last visit of previous study

Data type

boolean

Alias
UMLS CUI [1,1]
C0805732
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C2242969
Written informed consent obtained from the parent(s) or guardian(s) of the subject
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Planned use of any investigational or non-registered drug or vaccine during the study period
Description

Planned use of investigational or non-registered drug/vaccine during study period

Data type

boolean

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C2347804
UMLS CUI [2,1]
C1301732
UMLS CUI [2,2]
C1517586
UMLS CUI [2,3]
C0042210
UMLS CUI [2,4]
C0347984
UMLS CUI [2,5]
C2347804
Simultaneous participation in any other clinical trial
Description

Simultaneous other clinical trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348568
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Similar models

Visit 1: Eligibility Criteria

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Eligibility Check
C0013893 (UMLS CUI-1)
Entry criteria met
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Completion of last visit of previous study
Item
Completion of Visit 7, Month 21 of Malaria-026
boolean
C0805732 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C2242969 (UMLS CUI [1,4])
Informed Consent
Item
Written informed consent obtained from the parent(s) or guardian(s) of the subject
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Planned use of investigational or non-registered drug/vaccine during study period
Item
Planned use of any investigational or non-registered drug or vaccine during the study period
boolean
C1301732 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C1301732 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
C0347984 (UMLS CUI [2,4])
C2347804 (UMLS CUI [2,5])
Simultaneous other clinical trial
Item
Simultaneous participation in any other clinical trial
boolean
C0205394 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
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