English

Vaccination administration

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
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Workbook number
Description

Workbook number

Data type

integer

Alias
UMLS CUI [1]
C2986015
Visit number
Description

Visit number

Data type

integer

Alias
UMLS CUI [1]
C1549755
Vaccination administration
Description

Vaccination administration

Alias
UMLS CUI-1
C2368628
Date of administration of Vaccine
Description

fill in only if different from visit date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
Pre-Vaccination temperature
Description

Pre-Vaccination temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Site of temperature measurement
Description

Site of temperature measurement

Data type

text

Alias
UMLS CUI [1]
C0489453
Vaccine administration
Description

Please fill in this repeating Itemgroup for both vaccines. The side/site route for 10Pn-PD-DiT or HBV Vaccine: right thigh i.m. The side/site route for Infanrix Hexa or DTPa-IPV/Hib Vaccine: left thigh i.m.

Data type

integer

Alias
UMLS CUI [1]
C2368628
Vaccine administration
Description

If not administered please give reason and complete associated "Reason for non-administration" .

Data type

text

Alias
UMLS CUI [1]
C2368628
If Replacement Vial, specify Identifier
Description

Replacement vial

Data type

integer

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0600091
If Wrong vial number, specify Identifier
Description

Wrong vial number

Data type

integer

Alias
UMLS CUI [1]
C0184301
Has the study vaccine been administered according to the Protocol? If no please tick all items that apply
Description

Administration according to protocol: 10Pn-PD-DiT or HBV Vaccine: right thigh i.m. Infanrix Hexa or DTPa-IPV/Hib Vaccine: left thigh i.m.

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
Side?
Description

Side

Data type

text

Alias
UMLS CUI [1]
C0441987
Site?
Description

Site

Data type

integer

Alias
UMLS CUI [1]
C1515974
Route?
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Reason for non-administration
Description

Reason for non-administration

Alias
UMLS CUI-1
C1533734
UMLS CUI-2
C0392360
UMLS CUI-3
C1272696
Why not administered?
Description

Please tick the major reason for non administration

Data type

text

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0566251
Please complete and submit SAE report, specify SAE No
Description

SAE report, SAE No

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0684224
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0449788
Please complete Non-serious Adverse Event section, specify AE No
Description

Non-serious Adverse Event report

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Other reason for non administration, please specify (e.g.: consent withdrawal, Protocol violation,...)
Description

Other reason for non administration

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1298908
UMLS CUI [1,4]
C2368628
Please tick who made the decision
Description

Decision made by Investigator/parents/guardians

Data type

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C0402112
UMLS CUI [2,1]
C0679006
UMLS CUI [2,2]
C0030551
UMLS CUI [3,1]
C0679006
UMLS CUI [3,2]
C0023226
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Similar models

Vaccination administration

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])
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
Visit number
integer
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
Visit 1 (1)
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 6 (6)
Item Group
Vaccination administration
C2368628 (UMLS CUI-1)
Date of administration of Vaccine
Item
Date of administration of Vaccine
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1])
Item
Site of temperature measurement
text
C0489453 (UMLS CUI [1])
Route
Code List
Site of temperature measurement
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
CL Item
Tympanic (oral conversion) (X)
CL Item
Tympanic (rectal conversion) (Y)
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1])
Vaccine administration
Code List
Vaccine administration
CL Item
10Pn-PD-DiT or HBV Vaccine (1)
CL Item
Infanrix Hexa or DTPa-IPV/Hib Vaccine (2)
Item
Vaccine administration
text
C2368628 (UMLS CUI [1])
Vaccine administration: Infanrix Hexa or DTPa-IPV/Hib Vaccine
Code List
Vaccine administration
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (N)
Replacement vial
Item
If Replacement Vial, specify Identifier
integer
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Wrong vial number
Item
If Wrong vial number, specify Identifier
integer
C0184301 (UMLS CUI [1])
Vaccine administered according to the Protocol
Item
Has the study vaccine been administered according to the Protocol? If no please tick all items that apply
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item
Side?
text
C0441987 (UMLS CUI [1])
Side
Code List
Side?
CL Item
Left (L)
CL Item
Right (R)
Item
Site?
integer
C1515974 (UMLS CUI [1])
Site
Code List
Site?
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route?
text
C0013153 (UMLS CUI [1])
Site
Code List
Route?
CL Item
I.M. (M)
CL Item
S.C. (SC)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Reason for non-administration
C1533734 (UMLS CUI-1)
C0392360 (UMLS CUI-2)
C1272696 (UMLS CUI-3)
Item
Why not administered?
text
C1298908 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Vaccination not administered
Code List
Why not administered?
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Other (OTH)
SAE report, SAE No
Item
Please complete and submit SAE report, specify SAE No
integer
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0449788 (UMLS CUI [2,2])
Non-serious Adverse Event report
Item
Please complete Non-serious Adverse Event section, specify AE No
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Other reason for non administration
Item
Other reason for non administration, please specify (e.g.: consent withdrawal, Protocol violation,...)
text
C0205394 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,4])
Item
Please tick who made the decision
text
C0679006 (UMLS CUI [1,1])
C0402112 (UMLS CUI [1,2])
C0679006 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0679006 (UMLS CUI [3,1])
C0023226 (UMLS CUI [3,2])
Decision made
Code List
Please tick who made the decision
CL Item
Investigator  (I)
CL Item
Parents/Guardians (P)
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