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Visit 3: Study Continuation Check

1 Formulär  
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beskrivning

45 months post dose 1 in Malaria-026 (12 months after visit 2)

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Check for Study Continuation
Beskrivning

Check for Study Continuation

Alias
UMLS CUI-1
C2348568
UMLS CUI-2
C0805733
Did the subject return for visit 3?
Beskrivning

If yes, please complete the next pages. If no, please complete below.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Same reason and decision as previous visit
Beskrivning

withdrawal reason and decision same as previously

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C2127115
UMLS CUI [2,1]
C0422727
UMLS CUI [2,2]
C0679006
UMLS CUI [2,3]
C2127115
If No, please tick one most appropriate reason
Beskrivning

Reason for discontinuation

Datatyp

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
If Serious adverse event, please specify the SAE number
Beskrivning

SAE number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C1519255
If Other, please specify
Beskrivning

specify other reason

Datatyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C1521902
Please tick who took the decision
Beskrivning

Withdrawal decision

Datatyp

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
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Similar models

Visit 3: Study Continuation Check

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Check for Study Continuation
C2348568 (UMLS CUI-1)
C0805733 (UMLS CUI-2)
return for visit
Item
Did the subject return for visit 3?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
withdrawal reason and decision same as previously
Item
Same reason and decision as previous visit
boolean
C0457454 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C2127115 (UMLS CUI [1,4])
C0422727 (UMLS CUI [2,1])
C0679006 (UMLS CUI [2,2])
C2127115 (UMLS CUI [2,3])
Item
If No, please tick one most appropriate reason
text
C0566251 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
If No, please tick one most appropriate reason
Code List
If No, please tick one most appropriate reason
CL Item
Serious adverse event (1)
CL Item
Other (2)
SAE number
Item
If Serious adverse event, please specify the SAE number
integer
C0600091 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
specify other reason
Item
If Other, please specify
text
C3840932 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Item
Please tick who took the decision
text
C0679006 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Please tick who took the decision
Code List
Please tick who took the decision
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
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