Inglese

Check for continuation, elimination criteria, physical examination

1 moduli  
Administrative data
Descrizione

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Descrizione

Subject number

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Visit number
Descrizione

Visit number

Tipo di dati

integer

Alias
UMLS CUI [1]
C1549755
Date of Visit
Descrizione

Date of Visit

Tipo di dati

date

Alias
UMLS CUI [1]
C1320303
Workbook number
Descrizione

Workbook number

Tipo di dati

integer

Alias
UMLS CUI [1]
C2986015
CHECK FOR STUDY CONTINUATION
Descrizione

CHECK FOR STUDY CONTINUATION

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject return for visit?
Descrizione

If subject return to visit please complete the next pages

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
No return to visit
Descrizione

Please tick the ONE most appropriate reason and skip the following pages of this visit. If there is a SAE please complete and submit SAE report. If there is a AEX please complete Non-serious Adverse Event section. If there is an other reason for no return please specify in following item.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C0805733
UMLS CUI [1,4]
C0566251
If SAE Number
Descrizione

Please complete and submit SAE report

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
If AE Number please specify
Descrizione

Please complete Non-serious Adverse Event section

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
If solicited AE Code
Descrizione

In workbook 1 and 2 only for immuno and reato subset.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0683368
UMLS CUI [1,2]
C1517001
UMLS CUI [1,3]
C1518404
UMLS CUI [1,4]
C0805701
If other reason for no return
Descrizione

(e.g.: consent withdrawal, Protocol violation, …)

Tipo di dati

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C0805733
who made the decision
Descrizione

Decision made by Investigator, Parents/Guardians

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C0008961
UMLS CUI [2,1]
C0679006
UMLS CUI [2,2]
C0030551
UMLS CUI [2,3]
C0023226
ELIMINATION CRITERIA
Descrizione

ELIMINATION CRITERIA

Alias
UMLS CUI-1
C0680251
Did any elimination criteria become applicable since last visit?
Descrizione

Please tick all that applies in following items. Note: Please check exclusion criteria for further participation (only if subject returns at the visit)

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1706839
Same reason and decision as previous visit.
Descrizione

For Visit 3-9

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0445247
UMLS CUI [1,3]
C0205156
UMLS CUI [1,4]
C0545082
Chronic administration of immunosuppressants or other immune-modifying drugs.
Descrizione

Chronic administration is defined as more than 14 days

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0021081
UMLS CUI [2,2]
C0205191
UMLS CUI [3]
C0005525
Major congenital defects or serious chronic illness.
Descrizione

Elimination criteria: Major congenital defects/serious chronic illness.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0220810
UMLS CUI [2,2]
C0205164
UMLS CUI [3,1]
C0008679
UMLS CUI [3,2]
C0205404
Any confirmed or suspected immunosuppressive or immunodeficient condition.
Descrizione

Elimination criteria: confirmed/suspected immunosuppressive/immunodeficient condition.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0750484
UMLS CUI [2,2]
C3829792
UMLS CUI [3,1]
C0750484
UMLS CUI [3,2]
C4048329
UMLS CUI [4,1]
C0242114
UMLS CUI [4,2]
C3829792
UMLS CUI [5,1]
C0242114
UMLS CUI [5,2]
C4048329
Administration of immunoglobulins and/or any blood derived products.
Descrizione

Elimination criteria: immunoglobulins/any blood derived products

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0021027
UMLS CUI [3]
C0456388
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s).
Descrizione

Elimination criteria: use of investigational or non-registered product

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0042210
UMLS CUI [2,4]
C2348563
Physical examination
Descrizione

Physical examination

Alias
UMLS CUI-1
C0031809
Height
Descrizione

Height

Tipo di dati

integer

Unità di misura
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Descrizione

Weight

Tipo di dati

float

Unità di misura
  • kg
Alias
UMLS CUI [1]
C0005910
kg
ADDITIONAL IMMUNO ICF
Descrizione

ADDITIONAL IMMUNO ICF

Alias
UMLS CUI-1
C0021430
Did the parents/guardians sign the additional immuno ICF?
Descrizione

If yes please complete blood sample question at this visit (if visit is performed) and perform Visit 7. Note: → All parents/guardians who signed their initial ICF of the group “All subjects” or “Carriage” and decided to be part of the Additional IR subgroup must answer “Yes” to this question. → All parents/guardians who did not perform Visit 6 must answer “NA” to this question.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
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Similar models

Check for continuation, elimination criteria, physical examination

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Visit number
integer
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
CL Item
Visit 6 (6)
CL Item
Visit 7 (7)
CL Item
Visit 8 (8)
CL Item
Visit 9 (9)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item
Workbook number
integer
C2986015 (UMLS CUI [1])
Workbook number
Code List
Workbook number
CL Item
workbook 1 (1)
CL Item
workbook 2 (2)
CL Item
workbook 3 (3)
Item Group
CHECK FOR STUDY CONTINUATION
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Return to visit
Item
Did the subject return for visit?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
Item
No return to visit
text
C1298908 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0805733 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
No return to visit, reason
Code List
No return to visit
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Other (OTH)
SAE Number
Item
If SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Item
If AE Number please specify
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Solicited AE Code
Item
If solicited AE Code
text
C0683368 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
Other reason for no return
Item
If other reason for no return
text
C3840932 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C0805733 (UMLS CUI [1,3])
Item
who made the decision
text
C0679006 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0679006 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0023226 (UMLS CUI [2,3])
Decision made by Investigator, Parents/Guardians
Code List
who made the decision
CL Item
Investigator  (I)
CL Item
Parents/Guardians (P)
Item Group
ELIMINATION CRITERIA
C0680251 (UMLS CUI-1)
Elimination criteria become applicable
Item
Did any elimination criteria become applicable since last visit?
boolean
C0680251 (UMLS CUI [1,1])
C1706839 (UMLS CUI [1,2])
Same reason and decision as previous visit.
Item
Same reason and decision as previous visit.
boolean
C0566251 (UMLS CUI [1,1])
C0445247 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
Elimination criteria: immunosuppressants/immune-modifying drugs
Item
Chronic administration of immunosuppressants or other immune-modifying drugs.
boolean
C0680251 (UMLS CUI [1])
C0021081 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0005525 (UMLS CUI [3])
Elimination criteria: Major congenital defects/serious chronic illness.
Item
Major congenital defects or serious chronic illness.
boolean
C0680251 (UMLS CUI [1])
C0220810 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0008679 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
Elimination criteria: confirmed/suspected immunosuppressive/immunodeficient condition.
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition.
boolean
C0680251 (UMLS CUI [1])
C0750484 (UMLS CUI [2,1])
C3829792 (UMLS CUI [2,2])
C0750484 (UMLS CUI [3,1])
C4048329 (UMLS CUI [3,2])
C0242114 (UMLS CUI [4,1])
C3829792 (UMLS CUI [4,2])
C0242114 (UMLS CUI [5,1])
C4048329 (UMLS CUI [5,2])
Elimination criteria: immunoglobulins/any blood derived products
Item
Administration of immunoglobulins and/or any blood derived products.
boolean
C0680251 (UMLS CUI [1])
C0021027 (UMLS CUI [2])
C0456388 (UMLS CUI [3])
Elimination criteria: use of investigational or non-registered product
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s).
boolean
C0680251 (UMLS CUI [1])
C0304229 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
ADDITIONAL IMMUNO ICF
C0021430 (UMLS CUI-1)
Item
Did the parents/guardians sign the additional immuno ICF?
integer
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
ICF signed for additional immuno by parents/guardians
Code List
Did the parents/guardians sign the additional immuno ICF?
CL Item
No (1)
CL Item
Yes (2)
CL Item
NA (3)
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