0 Evaluaciones
ID

41661

Descripción

Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 https://clinicaltrials.gov/ct2/show/NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). This form (Screening Conclusion) is to be filled out at Visit 1 (Day -28 to day 0).

Link

https://clinicaltrials.gov/ct2/show/NCT00307021

Palabras clave

Versiones (2)
  1. 01/12/2020 01/12/2020 -
  2. 05/12/2020 05/12/2020 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

5 de dezembro de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 4.0
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    Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021

    Inglés

    Screening Conclusion

    1 formularios  
    1. StudyEvent: ODM
      1. Screening Conclusion
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Centre number
    Descripción

    Centre number

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    UMLS CUI [1,2]
    C0019994 (Hospitals)
    Subject number
    Descripción

    Subject number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Treatment number
    Descripción

    Treatment number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1522541 (Protocol Treatment Arm)
    Date of visit
    Descripción

    Date of visit

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Screening Conclusion
    Descripción

    Screening Conclusion

    Alias
    UMLS CUI-1
    C1710477 (Trial Screening)
    UMLS CUI-2
    C1707478 (Conclusion)
    Did the subject experience any Serious Adverse Event during screening? (only SAE related to study participation or to a concurrent medication need to be considered and reported)
    Descripción

    SAE during screening

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255 (Serious Adverse Event)
    UMLS CUI [1,2]
    C0347984 (During)
    SNOMED
    371881003
    UMLS CUI [1,3]
    C1710477 (Trial Screening)
    If yes, specify total number of SAEs
    Descripción

    Number of SAEs during screening

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0449788 (Count of entities)
    SNOMED
    410681005
    UMLS CUI [1,2]
    C1519255 (Serious Adverse Event)
    UMLS CUI [1,3]
    C0347984 (During)
    SNOMED
    371881003
    UMLS CUI [1,4]
    C1710477 (Trial Screening)
    Is the subject a screening failure? (Was the subject withdrawn prior to randomization or first vaccination?)
    Descripción

    Screen failure (withdrawn prior to randomization or first vaccination)

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1710476 (Trial Screen Failure)
    UMLS CUI [2,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [2,2]
    C0332152 (Before)
    SNOMED
    236874000
    UMLS CUI [2,3]
    C0034656 (Randomization)
    UMLS CUI [3,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [3,2]
    C0332152 (Before)
    SNOMED
    236874000
    UMLS CUI [3,3]
    C0205435 (First (number))
    SNOMED
    255216001
    LOINC
    LP96880-7
    UMLS CUI [3,4]
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    If yes, provide Major reason for failure (tick one box only)
    Descripción

    Major reason for screening failure

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1710476 (Trial Screen Failure)
    UMLS CUI [1,2]
    C1542147 (Main)
    UMLS CUI [1,3]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    If protocol violation, please specify
    Descripción

    Reason for screening failure: protocol violation

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1710476 (Trial Screen Failure)
    UMLS CUI [1,2]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    UMLS CUI [1,3]
    C1709750 (Protocol Violation)
    UMLS CUI [1,4]
    C2348235 (Specification)
    If SAE please specify SAE No.
    Descripción

    Reason for screening failure: SAE

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1710476 (Trial Screen Failure)
    UMLS CUI [1,2]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    UMLS CUI [1,3]
    C1519255 (Serious Adverse Event)
    UMLS CUI [1,4]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    If other reason, please specify
    Descripción

    Other reason for screening failure

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1710476 (Trial Screen Failure)
    UMLS CUI [1,2]
    C3840932 (Other Reason)
    LOINC
    LA6535-4
    UMLS CUI [1,3]
    C2348235 (Specification)
    Who made the decision?
    Descripción

    Decision

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0679006 (Decision)
    UMLS CUI [1,2]
    C1710476 (Trial Screen Failure)
    Investigator's signature
    Descripción

    Investigator's signature

    Alias
    UMLS CUI-1
    C2346576 (Investigator Signature)
    Investigator's signature
    Descripción

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

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
    Date
    Descripción

    Date of investigator's signature

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C2346576 (Investigator Signature)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Printed Investigator's name
    Descripción

    Printed Investigator's name

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826892 (Investigator Name)
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    Similar models

    Screening Conclusion

    1 formularios
    1. StudyEvent: ODM
      1. Screening Conclusion
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Centre number
    Item
    Centre number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Treatment number
    Item
    Treatment number
    text
    C1522541 (UMLS CUI [1])
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Screening Conclusion
    C1710477 (UMLS CUI-1)
    C1707478 (UMLS CUI-2)
    Item
    Did the subject experience any Serious Adverse Event during screening? (only SAE related to study participation or to a concurrent medication need to be considered and reported)
    text
    C1519255 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C1710477 (UMLS CUI [1,3])
    SAE during screening
    Code List
    Did the subject experience any Serious Adverse Event during screening? (only SAE related to study participation or to a concurrent medication need to be considered and reported)
    CL Item
    No (N)
    CL Item
    Yes, specify total number of SAEs (Y)
    Number of SAEs during screening
    Item
    If yes, specify total number of SAEs
    integer
    C0449788 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    C0347984 (UMLS CUI [1,3])
    C1710477 (UMLS CUI [1,4])
    Item
    Is the subject a screening failure? (Was the subject withdrawn prior to randomization or first vaccination?)
    text
    C1710476 (UMLS CUI [1])
    C0422727 (UMLS CUI [2,1])
    C0332152 (UMLS CUI [2,2])
    C0034656 (UMLS CUI [2,3])
    C0422727 (UMLS CUI [3,1])
    C0332152 (UMLS CUI [3,2])
    C0205435 (UMLS CUI [3,3])
    C0042196 (UMLS CUI [3,4])
    Screen failure (withdrawn prior to randomization or first vaccination)
    Code List
    Is the subject a screening failure? (Was the subject withdrawn prior to randomization or first vaccination?)
    CL Item
    No (N)
    CL Item
    Yes, provide major reason for failure (Y)
    Item
    If yes, provide Major reason for failure (tick one box only)
    text
    C1710476 (UMLS CUI [1,1])
    C1542147 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Major reason for screening failure
    Code List
    If yes, provide Major reason for failure (tick one box only)
    CL Item
    Eligibility criteria not fulfilled (inclusion and exclusion criteria; please tick failing criteria on Eligibility form) (ELI)
    CL Item
    Protocol violation, please specify (PTV)
    CL Item
    Serious Adverse Event (please complete and submit SAE report and specify SAE No.) (SAE)
    CL Item
    Consent withdrawal / not willing to participate, 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, please specify (OTH)
    Reason for screening failure: protocol violation
    Item
    If protocol violation, please specify
    text
    C1710476 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C1709750 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Reason for screening failure: SAE
    Item
    If SAE please specify SAE No.
    integer
    C1710476 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [1,3])
    C0237753 (UMLS CUI [1,4])
    Other reason for screening failure
    Item
    If other reason, please specify
    text
    C1710476 (UMLS CUI [1,1])
    C3840932 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Who made the decision?
    text
    C0679006 (UMLS CUI [1,1])
    C1710476 (UMLS CUI [1,2])
    Decision
    Code List
    Who made the decision?
    CL Item
    Investigator (I)
    CL Item
    Parents/Guardian (P)
    Item Group
    Investigator's signature
    C2346576 (UMLS CUI-1)
    Investigator's signature
    Item
    Investigator's signature
    text
    C2346576 (UMLS CUI [1])
    Date of investigator's signature
    Item
    Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Printed Investigator's name
    Item
    Printed Investigator's name
    text
    C2826892 (UMLS CUI [1])
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