ID

33018

Beschrijving

Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella CRF Seiten: 268-336; 870-938

Trefwoorden

Versies (1)
  1. 23-11-18 23-11-18 -
Houder van rechten

GSK group of companies

Geüploaded op

23 november 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Immunogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020

Engels

Visit 3: Study Continuation Check

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Subject Number
Beschrijving

Subject Number

Datatype

integer

Visit
Beschrijving

42-56 days after Visit 2

Datatype

text

Check for Study Continuation
Beschrijving

Check for Study Continuation

Did the subject return for visit 3?
Beschrijving

Did the subject return for visit 3?

Datatype

boolean

If YES, Same reason and decision as previous visit?
Beschrijving

If YES, Same reason and decision as previous visit?

Datatype

boolean

If Different reason, complete below
Beschrijving

If Different reason, complete below

Datatype

text

If no, please tick the ONE most appropriate reason and skip the following pages of this visit.
Beschrijving

If no, please tick the ONE most appropriate reason and skip the following pages of this visit.

Datatype

text

If Other, please specify
Beschrijving

If Other, please specify

Datatype

text

If Non-serious AE, please specify unsolicited AE Number
Beschrijving

If Non-serious AE, please specify unsolicited AE Number

Datatype

integer

if SAE, please specify SAE Number
Beschrijving

if SAE, please specify SAE Number

Datatype

integer

Please Tick who took the decision to withdraw from continuation
Beschrijving

Please Tick who took the decision to withdraw from continuation

Datatype

text

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Similar models

Visit 3: Study Continuation Check

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item
Visit
text
Visit
Code List
Visit
CL Item
Visit 3 (1)
Item Group
Check for Study Continuation
Did the subject return for visit 3?
Item
Did the subject return for visit 3?
boolean
If YES, Same reason and decision as previous visit?
Item
If YES, Same reason and decision as previous visit?
boolean
If Different reason, complete below
Item
If Different reason, complete below
text
Item
If no, please tick the ONE most appropriate reason and skip the following pages of this visit.
text
If no, please tick the ONE most appropriate reason and skip the following pages of this visit.
Code List
If no, please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
[SAE] Serious Adverse Event (complete the SAE form) (1)
CL Item
[AEX] Non-Serious adverse event (complete the Non-serious AE form) (2)
CL Item
Other (3)
If Other, please specify
Item
If Other, please specify
text
If Non-serious AE, please specify unsolicited AE Number
Item
If Non-serious AE, please specify unsolicited AE Number
integer
if SAE, please specify SAE Number
Item
if SAE, please specify SAE Number
integer
Item
Please Tick who took the decision to withdraw from continuation
text
Please Tick who took the decision to withdraw from continuation
Code List
Please Tick who took the decision to withdraw from continuation
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
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