ID

33084

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

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Versies (1)
  1. 26-11-18 26-11-18 -
Houder van rechten

GSK group of companies

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26 november 2018

DOI

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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

Study Conclusion Form

1 Formulieren  
  1. StudyEvent: ODM
    1. Study Conclusion Form
Administrative data
Beschrijving

Administrative data

Subject Number
Beschrijving

Subject Number

Datatype

integer

Occurrence of Serious Adverse Event
Beschrijving

Occurrence of Serious Adverse Event

Did the subject experience any Serious Adverse Events during the study period?
Beschrijving

Did the subject experience any Serious Adverse Events during the study period?

Datatype

boolean

If Yes, please specify total number of SAE's
Beschrijving

If Yes, please specify total number of SAE's

Datatype

integer

Status of treatment blind
Beschrijving

Status of treatment blind

Was the treatment blind broken during this study?
Beschrijving

For the control group, please tick 'No'

Datatype

boolean

If Yes, please complete date
Beschrijving

If Yes, please complete date

Datatype

date

Check the reason of blind breach
Beschrijving

Check the reason of blind breach

Datatype

integer

If Other, specify
Beschrijving

complete Non-Serious Adverse Event section or Serious Adverse Event form as appropriate

Datatype

text

Elimination Criteria
Beschrijving

Elimination Criteria

Did any elimination criteria become applicable during the study?
Beschrijving

Did any elimination criteria become applicable during the study?

Datatype

boolean

If Yes, specify
Beschrijving

If Yes, specify

Datatype

text

Was the subject withdrawn from study?
Beschrijving

Was the subject withdrawn from study?

Datatype

boolean

If Yes, please tick the ONE most appropriate category for withdrawal
Beschrijving

If Yes, please tick the ONE most appropriate category for withdrawal

Datatype

text

If SAE, please specify SAE Number
Beschrijving

If SAE, please specify SAE Number

Datatype

integer

If Non-SAE please specify unsolicited AE Number
Beschrijving

If Non-SAE please specify unsolicited AE Number

Datatype

integer

If Protocol violation, please specify
Beschrijving

If Protocol violation, please specify

Datatype

text

If Other, please specify
Beschrijving

If Other, please specify

Datatype

text

Please tick who took decision
Beschrijving

Please tick who took decision

Datatype

text

Date of last contact
Beschrijving

Date of last contact

Datatype

date

Was the subject in good condition at date of last contact?
Beschrijving

Was the subject in good condition at date of last contact?

Datatype

text

Investigator's Signature
Beschrijving

Investigator's Signature

I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my collegues is, to the best of my knowledge, complete and accurate, as of the date below.
Beschrijving

I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my collegues is, to the best of my knowledge, complete and accurate, as of the date below.

Datatype

date

Investigator's signature
Beschrijving

Investigator's signature

Datatype

text

Printed Investigator's name
Beschrijving

Printed Investigator's name

Datatype

text

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Similar models

Study Conclusion Form

1 Formulieren
  1. StudyEvent: ODM
    1. Study Conclusion Form
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Occurrence of Serious Adverse Event
Did the subject experience any Serious Adverse Events during the study period?
Item
Did the subject experience any Serious Adverse Events during the study period?
boolean
If Yes, please specify total number of SAE's
Item
If Yes, please specify total number of SAE's
integer
Item Group
Status of treatment blind
Was the treatment blind broken during this study?
Item
Was the treatment blind broken during this study?
boolean
If Yes, please complete date
Item
If Yes, please complete date
date
Item
Check the reason of blind breach
integer
Check the reason of blind breach
Code List
Check the reason of blind breach
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
Other (2)
If Other, specify
Item
If Other, specify
text
Item Group
Elimination Criteria
Did any elimination criteria become applicable during the study?
Item
Did any elimination criteria become applicable during the study?
boolean
If Yes, specify
Item
If Yes, specify
text
Was the subject withdrawn from study?
Item
Was the subject withdrawn from study?
boolean
Item
If Yes, please tick the ONE most appropriate category for withdrawal
text
If Yes, please tick the ONE most appropriate category for withdrawal
Code List
If Yes, please tick the ONE most appropriate category for withdrawal
CL Item
Serious adverse event (check SAE number) (1)
CL Item
Non-Serious adverse events (check the Non-SAE) (2)
CL Item
Protocol violation (3)
CL Item
Consent withdrawal, not due to an adverse event (4)
CL Item
Migrated/moved from the study area (5)
CL Item
Lost to follow-up (6)
CL Item
Other (7)
If SAE, please specify SAE Number
Item
If SAE, please specify SAE Number
integer
If Non-SAE please specify unsolicited AE Number
Item
If Non-SAE please specify unsolicited AE Number
integer
If Protocol violation, please specify
Item
If Protocol violation, please specify
text
If Other, please specify
Item
If Other, please specify
text
Item
Please tick who took decision
text
Please tick who took decision
Code List
Please tick who took decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Date of last contact
Item
Date of last contact
date
Item
Was the subject in good condition at date of last contact?
text
Was the subject in good condition at date of last contact?
Code List
Was the subject in good condition at date of last contact?
CL Item
Yes (1)
CL Item
No, please give details within the Adverse Events section (2)
Item Group
Investigator's Signature
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my collegues is, to the best of my knowledge, complete and accurate, as of the date below.
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my collegues is, to the best of my knowledge, complete and accurate, as of the date below.
date
Investigator's signature
Item
Investigator's signature
text
Printed Investigator's name
Item
Printed Investigator's name
text
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