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Vaccine Administration

1 forms  
  1. StudyEvent: ODM
    1. Vaccine Administration
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit number
Description

Visit number

Data type

integer

Alias
UMLS CUI [1]
C1549755
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Vaccine Administration
Description

Vaccine Administration

Alias
UMLS CUI-1
C2368628
Date
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

Body temperature before vaccination

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
°C
Pre-vaccination temperature route
Description

Please consider axillary measurement [A] to be the preferable route.

Data type

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0449687
Vaccine administration
Description

Only one box must be ticked by vaccine. If replacement vial [R], please specify the replacement vial number below. If wrong vial number [W], please specify the wrong number below. If not administered [N], please fill reasons in the next item group.

Data type

text

Alias
UMLS CUI [1]
C2368628
If replacement vial [R], please specify the replacement vial identifier.
Description

Vaccine administration vial device replacement identifier

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0184301
UMLS CUI [1,3]
C0559956
UMLS CUI [1,4]
C0600091
If wrong vial number [W], please specify the wrong identifier.
Description

Vaccine administration vial device wrong identifier

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0184301
UMLS CUI [1,3]
C3827420
UMLS CUI [1,4]
C0600091
Has the study vaccine been administered according to the Protocol?
Description

Side / site / route according to protocol: Left / Deltoid / I.M.

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
If not administered according to protocol, please tick side that applies.
Description

Side drug administration of vaccine

Data type

text

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C2368628
If not administered according to protocol, please tick anatomic site that applies.
Description

Anatomic site administration of vaccine

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C2368628
If not administered according to protocol, please tick route that applies.
Description

Route administration of vaccine

Data type

text

Alias
UMLS CUI [1,1]
C0449444
UMLS CUI [1,2]
C2368628
Vaccine Administration
Description

Vaccine Administration

Alias
UMLS CUI-1
C2368628
Why not administered? Please tick the major reason for non-administration
Description

Non-administration of vaccine primary reason

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C0205225
If serious adverse event [SAE], please specify SAE No.
Description

If serious adverse event [SAE], please also complete and submit SAE report.

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1521902
If non-serious adverse event [AEX], please specify AE No.
Description

OR specify solicited adverse event code in the following item. If non-serious adverse event [AEX], please also complete the non-serious adverse event section.

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1521902
If non-serious adverse event [AEX], please specify solicited AE code.
Description

OR specify non-serious adverse event number in the previous item. If non-serious adverse event [AEX], please also complete the non-serious adverse event section.

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1517001
UMLS CUI [1,3]
C0805701
UMLS CUI [1,4]
C1521902
If other [OTH], please specify (e.g.: consent withdrawal, protocol violation, …).
Description

Non-administration of vaccine other reason to specify | consent withdrawal | protocol violation

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C1521902
UMLS CUI [2]
C1707492
UMLS CUI [3]
C1709750
Please tick who made the decision.
Description

Non-administration decision maker

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0679006
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Similar models

Vaccine Administration

1 forms
  1. StudyEvent: ODM
    1. Vaccine Administration
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Visit number
integer
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
visit 2 (dose 1) (2)
(Comment:en)
CL Item
visit 4 (dose 2) (4)
(Comment:en)
CL Item
visit 5 (dose 3) (5)
(Comment:en)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Vaccine Administration
C2368628 (UMLS CUI-1)
Date of vaccine administration
Item
Date
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Body temperature before vaccination
Item
Pre-vaccination temperature
float
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Pre-vaccination temperature route
text
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0449687 (UMLS CUI [1,4])
Route Body temperature
Code List
Pre-vaccination temperature route
CL Item
Axillary (preferably) ([A])
CL Item
Oral ([O])
CL Item
Rectal ([R])
Item
Vaccine administration
text
C2368628 (UMLS CUI [1])
Vaccine administration
Code List
Vaccine administration
CL Item
RTS,S/AS01E Vaccine or RTS,S/AS02D Vaccine ([S])
CL Item
Replacement vial ([R])
CL Item
Wrong vial number ([W])
CL Item
Not administered ([N])
Vaccine administration vial device replacement identifier
Item
If replacement vial [R], please specify the replacement vial identifier.
integer
C2368628 (UMLS CUI [1,1])
C0184301 (UMLS CUI [1,2])
C0559956 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Vaccine administration vial device wrong identifier
Item
If wrong vial number [W], please specify the wrong identifier.
integer
C2368628 (UMLS CUI [1,1])
C0184301 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Administration of vaccine according to study protocol
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item
If not administered according to protocol, please tick side that applies.
text
C0441987 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Side drug administration routes vaccines
Code List
If not administered according to protocol, please tick side that applies.
CL Item
Left ([L])
CL Item
Right ([R])
Item
If not administered according to protocol, please tick anatomic site that applies.
text
C1515974 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Side drug administration routes vaccines
Code List
If not administered according to protocol, please tick anatomic site that applies.
CL Item
Deltoid ([1])
CL Item
Thigh ([3])
CL Item
Buttock ([6])
Item
If not administered according to protocol, please tick route that applies.
text
C0449444 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Side drug administration routes vaccines
Code List
If not administered according to protocol, please tick route that applies.
CL Item
intramuscular ([IM])
CL Item
subcutaneous ([SC])
Item Group
Vaccine Administration
C2368628 (UMLS CUI-1)
Item
Why not administered? Please tick the major reason for non-administration
text
C2368628 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205225 (UMLS CUI [1,4])
No administration of vaccine primary reason
Code List
Why not administered? Please tick the major reason for non-administration
CL Item
Serious adverse event ([SAE])
CL Item
Non-serious adverse event ([AEX])
CL Item
Other ([OTH])
Serious adverse event number to specify
Item
If serious adverse event [SAE], please specify SAE No.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Non-serious adverse event number to specify
Item
If non-serious adverse event [AEX], please specify AE No.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
If non-serious adverse event [AEX], please specify solicited AE code.
text
C0877248 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Solicited adverse event code to specify
Code List
If non-serious adverse event [AEX], please specify solicited AE code.
CL Item
Fever ([FE])
CL Item
Irritability/Fussiness ([IR])
CL Item
Drowsiness ([DR])
CL Item
Loss of appetite ([LO])
Non-administration of vaccine other reason to specify | consent withdrawal | protocol violation
Item
If other [OTH], please specify (e.g.: consent withdrawal, protocol violation, …).
text
C2368628 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
C1707492 (UMLS CUI [2])
C1709750 (UMLS CUI [3])
Item
Please tick who made the decision.
text
C2368628 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Non-administration decision maker
Code List
Please tick who made the decision.
CL Item
Investigator  ([I])
CL Item
Parents/Guardians ([P])
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