Visit 2

1 forms
  1. StudyEvent: ODM
    1. Visit 2
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
Date of visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Continuation Status, Clinical Trials
Item
Did the subject return for visit 2?
boolean
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Continuation Status, Clinical Trials, Reason
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (Please specify SAE N°) (1)
CL Item
Non-Serious adverse event (Please specify unsolicited AE N° or solicited AE code) (2)
CL Item
Other, please specify (3)
Continuation Status, Clinical Trials, Reason
Item
Specify
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item
Please tick who took the decision
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Continuation Status, Clinical Trials, Decision
Code List
Please tick who took the decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
Vaccine Administration - Hib-MenCY-TT Group
C2368628 (UMLS CUI-1)
Administration of vaccine, Date in time
Item
Date (fill in only if different from visit date)
date
C2368628 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Body Temperature, Vaccination, Before
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Route
text
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,4])
Body Temperature, Vaccination, Before, Route
Code List
Route
CL Item
Axillary (preferably) (1)
CL Item
Oral (2)
CL Item
Tympanic (oral conversion)  (3)
CL Item
Tympanic (rectal conversion)  (4)
CL Item
Rectal (5)
Item
Vaccine Administration (only one box must be ticked by vaccine)
text
C2368628 (UMLS CUI [1])
Administration of vaccine
Code List
Vaccine Administration (only one box must be ticked by vaccine)
CL Item
Hib-MenCY-TT Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial  (3)
CL Item
Not administered (4)
CL Item
Infanrix® penta Vaccine (5)
CL Item
Replacement vial (6)
CL Item
Wrong vial  (7)
CL Item
Not administered (8)
CL Item
Prevenar® Vaccine (9)
CL Item
Replacement vial (10)
CL Item
Wrong vial  (11)
CL Item
Not administered (12)
Administration of vaccine, Vial Device, Replacement, Identifier
Item
Vaccine Administration - Replacement vial number
integer
C2368628 (UMLS CUI [1,1])
C0184301 (UMLS CUI [1,2])
C0559956 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Administration of vaccine, Vial Device, Wrong, Identifier
Item
Vaccine Administration - Wrong vial number
integer
C2368628 (UMLS CUI [1,1])
C0184301 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Item
Side / site route
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
C1515974 (UMLS CUI [1,4])
Administration of vaccine, Drug Administration Routes, Side, Anatomic site
Code List
Side / site route
CL Item
Upper Right Thigh, I.M. (1)
CL Item
Upper Left Thigh, I.M. (2)
CL Item
Lower Left Thigh, I.M. (3)
Administration of vaccine, Protocol Compliance
Item
Has the study vaccine been administered according to the Protocol ?
boolean
C2368628 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
Item
If No, Side
text
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Administration of vaccine, Side
Code List
If No, Side
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
Item
If No, Site
text
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Administration of vaccine, Anatomic site
Code List
If No, Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
If No, Route
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Administration of vaccine, Drug Administration Routes
Code List
If No, Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Administration of vaccine, Comment
Item
Comments
text
C2368628 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Administration of Vaccine - Lic MenC group
C2368628 (UMLS CUI-1)
Administration of vaccine, Date in time
Item
Date (fill in only if different from visit date)
date
C2368628 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Body Temperature, Vaccination, Before
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Route
text
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,4])
Body Temperature, Vaccination, Before, Route
Code List
Route
CL Item
Axillary (preferably) (1)
CL Item
Oral (2)
CL Item
Tympanic (oral conversion)  (3)
CL Item
Tympanic (rectal conversion)  (4)
CL Item
Rectal (5)
Item
Vaccine Administration (only one box must be ticked by vaccine)
text
C2368628 (UMLS CUI [1])
Administration of vaccine
Code List
Vaccine Administration (only one box must be ticked by vaccine)
CL Item
ActHIB® Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial  (3)
CL Item
Not administered (4)
CL Item
Infanrix® penta Vaccine (5)
CL Item
Replacement vial (6)
CL Item
Wrong vial  (7)
CL Item
Not administered (8)
CL Item
Prevenar® Vaccine (9)
CL Item
Replacement vial (10)
CL Item
Wrong vial  (11)
CL Item
Not administered (12)
CL Item
Meningitec® Vaccine (13)
CL Item
Replacement vial (14)
CL Item
Wrong vial  (15)
CL Item
Not administered (16)
Administration of vaccine, Vial Device, Replacement, Identifier
Item
Vaccine Administration - Replacement vial number
integer
C2368628 (UMLS CUI [1,1])
C0184301 (UMLS CUI [1,2])
C0559956 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Administration of vaccine, Vial Device, Wrong, Identifier
Item
Vaccine Administration - Wrong vial number
integer
C2368628 (UMLS CUI [1,1])
C0184301 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Item
Side / site route
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
C1515974 (UMLS CUI [1,4])
Administration of vaccine, Drug Administration Routes, Side, Anatomic site
Code List
Side / site route
CL Item
Upper Right Thigh, I.M. (1)
CL Item
Upper Left Thigh, I.M. (2)
CL Item
Lower Right Thigh, I.M. (3)
CL Item
Lower Left Thigh, I.M. (4)
Administration of vaccine, Protocol Compliance
Item
Has the study vaccine been administered according to the Protocol ?
boolean
C2368628 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
Item
If No, Side
text
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Administration of vaccine, Side
Code List
If No, Side
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
Item
If No, Site
text
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Administration of vaccine, Side
Code List
If No, Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
If No, Route
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Administration of vaccine, Side
Code List
If No, Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Administration of vaccine, Comment
Item
Comments
text
C2368628 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Administration of Vaccine - ActHIB group
C2368628 (UMLS CUI-1)
Administration of vaccine, Date in time
Item
Date (fill in only if different from visit date)
date
C2368628 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Body Temperature, Vaccination, Before
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Route
text
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,4])
Body Temperature, Vaccination, Before, Route
Code List
Route
CL Item
Axillary (preferably) (1)
CL Item
Oral (2)
CL Item
Tympanic (oral conversion)  (3)
CL Item
Tympanic (rectal conversion)  (4)
CL Item
Rectal (5)
Item
Vaccine Administration (only one box must be ticked by vaccine)
text
C2368628 (UMLS CUI [1])
Administration of vaccine
Code List
Vaccine Administration (only one box must be ticked by vaccine)
CL Item
ActHIB® Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial  (3)
CL Item
Not administered (4)
CL Item
Infanrix® penta Vaccine (5)
CL Item
Replacement vial (6)
CL Item
Wrong vial  (7)
CL Item
Not administered (8)
CL Item
Prevenar® Vaccine (9)
CL Item
Replacement vial (10)
CL Item
Wrong vial  (11)
CL Item
Not administered (12)
Administration of vaccine, Vial Device, Replacement, Identifier
Item
Vaccine Administration - Replacement vial number
integer
C2368628 (UMLS CUI [1,1])
C0184301 (UMLS CUI [1,2])
C0559956 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Administration of vaccine, Vial Device, Wrong, Identifier
Item
Vaccine Administration - Wrong vial number
integer
C2368628 (UMLS CUI [1,1])
C0184301 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Item
Side / site route
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
C1515974 (UMLS CUI [1,4])
Administration of vaccine, Drug Administration Routes, Side, Anatomic site
Code List
Side / site route
CL Item
Upper Right Thigh, I.M. (1)
CL Item
Upper Left Thigh, I.M. (2)
CL Item
Lower Left Thigh, I.M. (3)
Administration of vaccine, Protocol Compliance
Item
Has the study vaccine been administered according to the Protocol ?
boolean
C2368628 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
Item
If No, Side
text
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Administration of vaccine, Side
Code List
If No, Side
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
Item
If No, Site
text
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Administration of vaccine, Side
Code List
If No, Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
If No, Route
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Administration of vaccine, Side
Code List
If No, Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Administration of vaccine, Comment
Item
Comments
text
C2368628 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Vaccine Administration (continued)
C2368628 (UMLS CUI-1)
Item
Why not administered? Please tick the ONE most appropriate category for non administration
text
C2368628 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
Administration of Vaccine, Not-Done Reason
Code List
Why not administered? Please tick the ONE most appropriate category for non administration
CL Item
Serious adverse event (Please specify SAE N°) (1)
CL Item
Non-Serious adverse event (Please specify unsolicited AE N° or solicited AE code) (2)
CL Item
Other, please specify (e.g. consent withdrawal, recoil violation, ...) (3)
Item
Why not administered? - Specifications
text
C2368628 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
Administration of Vaccine, Not-Done Reason
Code List
Why not administered? - Specifications
Item
Please tick who took the decision
text
C2368628 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Administration of Vaccine, Not-Done Reason
Code List
Please tick who took the decision
CL Item
Investigator  (1)
CL Item
Parents/Guardians (2)
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