Workbook 2 Vaccination 1 Part 1 Group Control

Administrative Documentation
Descrição

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Descrição

Subject Number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
VACCINE ADMINISTRATION
Descrição

VACCINE ADMINISTRATION

Alias
UMLS CUI-1
C2368628
Date (fill in only if different from visit date) :
Descrição

Date of vaccination

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
Pre-Vaccination temperature:
Descrição

temperature

Tipo de dados

float

Unidades de medida
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
°C
Pre-Vaccination temperature: Route:
Descrição

Route of Measurement

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0449687
Vaccine administration (only one box must be ticked by vaccine)
Descrição

Vaccine Administration

Tipo de dados

text

Alias
UMLS CUI [1]
C2368628
(*) Why not administered ? Please tick the ONE most appropriate category for non administration :
Descrição

Reason Vaccine not administered

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Please tick who made the decision
Descrição

Decision

Tipo de dados

text

Alias
UMLS CUI [1]
C0679006
Side / Site Route: Left upper arm S.C.
Descrição

undefined item

Tipo de dados

text

Has the study vaccine been administered according to the protocol?
Descrição

Vaccine Administration

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2368628
Side
Descrição

Vaccine administration Side

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Site
Descrição

Vaccine administration site

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Route
Descrição

Vaccine administration route

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
IMMEDIATE POST-VACCINATION OBSERVATION If any adverse events occurred during the immediate post-vaccination time (30 minutes) please fill in the Solicited Adverse Events section, the Non-Serious Adverse Event section or a Serious Adverse Event form. If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick prophylactic box. Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section
Descrição

Post vaccination observation

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1443955
UMLS CUI [1,2]
C0700325

Similar models

Workbook 2 Vaccination 1 Part 1 Group Control

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
VACCINE ADMINISTRATION
C2368628 (UMLS CUI-1)
Date of vaccination
Item
Date (fill in only if different from visit date) :
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
temperature
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])
C0449687 (UMLS CUI [1,3])
Code List
Pre-Vaccination temperature: Route:
CL Item
Axillary (A)
CL Item
Rectal (R)
Item
Vaccine administration (only one box must be ticked by vaccine)
text
C2368628 (UMLS CUI [1])
Code List
Vaccine administration (only one box must be ticked by vaccine)
CL Item
MENCEVAX™ ACWY Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (Please complete below (*) ) (N)
Item
(*) Why not administered ? Please tick the ONE most appropriate category for non administration :
text
C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
(*) Why not administered ? Please tick the ONE most appropriate category for non administration :
CL Item
Serious adverse event (complete the Serious Adverse Event form) Please specify SAE N° (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) Please specify unsolicited AE N° or Solicited AE code (AEX)
CL Item
Other, please specify (OTH)
Item
Please tick who made the decision
text
C0679006 (UMLS CUI [1])
Code List
Please tick who made the decision
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
undefined item
Item
Side / Site Route: Left upper arm S.C.
text
Vaccine Administration
Item
Has the study vaccine been administered according to the protocol?
boolean
C2368628 (UMLS CUI [1])
Item
Side
text
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
CL Item
Upper Left (A)
CL Item
Lower Left (B)
CL Item
Upper Right (X)
CL Item
Lower Right (Y)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
CL Item
Deltoid (1)
CL Item
Thigh (3)
CL Item
Buttock (6)
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
CL Item
I.M. (M)
CL Item
S.C. (SC)
Post vaccination observation
Item
IMMEDIATE POST-VACCINATION OBSERVATION If any adverse events occurred during the immediate post-vaccination time (30 minutes) please fill in the Solicited Adverse Events section, the Non-Serious Adverse Event section or a Serious Adverse Event form. If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick prophylactic box. Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section
text
C1443955 (UMLS CUI [1,1])
C0700325 (UMLS CUI [1,2])