ID

35780

Beschrijving

Study ID: 110028 Clinical Study ID: 110028 Study Title: Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00510874 https://clinicaltrials.gov/ct2/show/NCT00510874 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine Trade Name: Pumarix, Pandemrix Study Indication: Influenza This study consists of 6 Visits and one Telephone Contact: -Visit 1: Visit „Day 0“ -Visit 2: Visit „Day 7“, Contact Window: Day 6-8, Minimum Number of Days between Successive Visits: 6 -Visit 3: Visit „Day 21“: Contact Window: Day 19-23, Minimum Number of Days between Successive Visits: 12 -Visit 4: Visit „Day 28“: Contact Window: Day 26-30, Minimum Number of Days between Successive Visits: 6 -Visit 5: Visit „Day 42“: Contact Window: Day 38-46, Minimum Number of Days between S ccessive Visits: 12 -Telephone Contact „Day 84“: Contact Window: Day 80-88 -Visit 6: Visit „Day 182“: Contact Window: Day 167-197 The screening can take place up to 21 days prior to Visit 1. This document contains the Screening conclusion form. It has to be filled in after the screening visit.

Link

https://clinicaltrials.gov/ct2/show/NCT00510874

Trefwoorden

Versies (2)
  1. 22-03-19 22-03-19 -
  2. 22-03-19 22-03-19 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

22 maart 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874

Engels

Screening conclusion

1 Formulieren  
  1. StudyEvent: ODM
    1. Screening conclusion
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Date of Screening
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1710477
Screening conclusion
Beschrijving

Screening conclusion

Alias
UMLS CUI-1
C1710477
UMLS CUI-2
C1707478
Did the subject experience any Serious Adverse Event during screening?
Beschrijving

only SAEs related to study participation or to a concurrent medication need to be considered and reported.

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710477
If subject experienced any SAE during sceening period, please specify total number of SAEs.
Beschrijving

SAE Number during screening

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1710477
Is the subject a screening failure?
Beschrijving

Was the subject withdrawn prior to randomisation or first vaccination?

Datatype

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
If the subject was a screening failure, please tick the major reason for failure
Beschrijving

(Tick one box only). If you tick ELI: Please tick failing criteria on Eligibility form. If you tick SAE: Please complete and submit SAE report. Please specify SAE No. in the "SAE Number" Item.

Datatype

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
Reason for failure in screening, specification
Beschrijving

Specify if you ticked "Protocol violation" or "Other" as major reason for failure.

Datatype

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
Who made the decision?
Beschrijving

Decision taken for screening failure

Datatype

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0679006
Investigator's Signature
Beschrijving

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Beschrijving

I confirm that I have reviewed the data in these screening forms for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

Datatype

text

Alias
UMLS CUI [1]
C2346576
Printed Investigator's name
Beschrijving

Printed Investigator's name

Datatype

text

Alias
UMLS CUI [1]
C2826892
Date of signature
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Screening conclusion

1 Formulieren
  1. StudyEvent: ODM
    1. Screening conclusion
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Date of Screening
Item
Date of Screening
date
C0011008 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
Item Group
Screening conclusion
C1710477 (UMLS CUI-1)
C1707478 (UMLS CUI-2)
Item
Did the subject experience any Serious Adverse Event during screening?
text
C1519255 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
SAE
Code List
Did the subject experience any Serious Adverse Event during screening?
CL Item
Yes (Y)
CL Item
No (N)
SAE Number during screening
Item
If subject experienced any SAE during sceening period, please specify total number of SAEs.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
Item
Is the subject a screening failure?
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Screening failure
Code List
Is the subject a screening failure?
CL Item
Yes (Y)
CL Item
No (N)
Item
If the subject was a screening failure, please tick the major reason for failure
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Screening failure
Code List
If the subject was a screening failure, please tick the major reason for failure
CL Item
Eligibility criteria not fulfilled (inclusion and exclusion criteria) (ELI)
CL Item
Protocol violation (PTV)
CL Item
Serious adverse event (SAE)
CL Item
Consent withdrawal not due to a serious adverse event (CWS)
CL Item
Migrated / moved from the study area (MIG)
CL Item
Lost to follow-up (LFU)
CL Item
Other (OTH)
Reason for failure in screening, specification
Item
Reason for failure in screening, specification
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Item
Who made the decision?
text
C1710476 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Decision taken
Code List
Who made the decision?
CL Item
Investigator (I)
CL Item
Subject (S)
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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