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ID

37756

Description

Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

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Versions (1)
  1. 8/22/19 8/22/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 22, 2019

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Creative Commons BY-NC 3.0
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    Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886

    English

    CRF Tracking/Review Forms

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Center number
    Description

    Study Coordinating Center, Identification number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2825181
    UMLS CUI [1,2]
    C1300638
    Patient Number
    Description

    Patient number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1830427
    Patient Initials
    Description

    Person Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    Investigator
    Description

    Investigator Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    CRF Tracking/Review Form
    Description

    CRF Tracking/Review Form

    Alias
    UMLS CUI-1
    C3889409
    Screening failure (archive only)
    Description

    Clinical Trial Regulatory Tracking Document, Trial Screening, Failed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3889409
    UMLS CUI [1,2]
    C1710477
    UMLS CUI [1,3]
    C0231175
    Module
    Description

    Clinical Trial Regulatory Tracking Document, Module

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3889409
    UMLS CUI [1,2]
    C1709061
    Module Description
    Description

    Clinical Trial Regulatory Tracking Document, Module, Description

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3889409
    UMLS CUI [1,2]
    C1709061
    UMLS CUI [1,3]
    C0678257
    Page Range
    Description

    Clinical Trial Regulatory Tracking Document, Page, Range

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3889409
    UMLS CUI [1,2]
    C1704732
    UMLS CUI [1,3]
    C1514721
    Modules
    Description

    Clinical Trial Regulatory Tracking Document, Module, Send

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3889409
    UMLS CUI [1,2]
    C1709061
    UMLS CUI [1,3]
    C1519246
    Missing pages (if applicable)
    Description

    Clinical Trial Regulatory Tracking Document, Page, Missing

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3889409
    UMLS CUI [1,2]
    C1704732
    UMLS CUI [1,3]
    C1705492
    Site Monitor's comments (e.g. protocol violations or deviations)
    Description

    Clinical Trial Regulatory Tracking Document, Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3889409
    UMLS CUI [1,2]
    C0947611
    Site Monitor's signature
    Description

    Clinical Trial Regulatory Tracking Document, Investigator Signature

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3889409
    UMLS CUI [1,2]
    C2346576
    Date Submitted
    Description

    Clinical Trial Regulatory Tracking Document, Investigator Signature, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3889409
    UMLS CUI [1,2]
    C2346576
    UMLS CUI [1,3]
    C0011008
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    Similar models

    CRF Tracking/Review Forms

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Study Coordinating Center, Identification number
    Item
    Center number
    integer
    C2825181 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    Patient number
    Item
    Patient Number
    integer
    C1830427 (UMLS CUI [1])
    Person Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Investigator Name
    Item
    Investigator
    text
    C2826892 (UMLS CUI [1])
    Item Group
    CRF Tracking/Review Form
    C3889409 (UMLS CUI-1)
    Clinical Trial Regulatory Tracking Document, Trial Screening, Failed
    Item
    Screening failure (archive only)
    boolean
    C3889409 (UMLS CUI [1,1])
    C1710477 (UMLS CUI [1,2])
    C0231175 (UMLS CUI [1,3])
    Item
    Module
    text
    C3889409 (UMLS CUI [1,1])
    C1709061 (UMLS CUI [1,2])
    Clinical Trial Regulatory Tracking Document, Module
    Code List
    Module
    CL Item
    MOD1 (1)
    CL Item
    SAE1 (2)
    CL Item
    SAE2 (3)
    CL Item
    SAE3 (4)
    CL Item
    SAE4 (5)
    CL Item
    SAE5 (6)
    CL Item
    FORMD (7)
    CL Item
    PSFM1 (8)
    CL Item
    PSFM2 (9)
    CL Item
    PSFM3 (10)
    CL Item
    PSFM4 (11)
    CL Item
    PSFM5 (12)
    CL Item
    PSFM6 (13)
    CL Item
    PSFM7 (14)
    CL Item
    PSFM8 (15)
    CL Item
    PSFU1 (16)
    CL Item
    PSFU2 (17)
    Item
    Module Description
    text
    C3889409 (UMLS CUI [1,1])
    C1709061 (UMLS CUI [1,2])
    C0678257 (UMLS CUI [1,3])
    Clinical Trial Regulatory Tracking Document, Module
    Code List
    Module Description
    CL Item
    Screening/Course 1 (1)
    CL Item
    Serious Adverse Experiences (2)
    CL Item
    Serious Adverse Experiences (3)
    CL Item
    Serious Adverse Experiences (4)
    CL Item
    Serious Adverse Experiences (5)
    CL Item
    Serious Adverse Experiences (6)
    CL Item
    Form D (7)
    CL Item
    Post-Study Minimal FU M3 (8)
    CL Item
    Post-Study Minimal FU M6 (9)
    CL Item
    Post-Study Minimal FU M9 (10)
    CL Item
    Post-Study Minimal FU M12 (11)
    CL Item
    Post-Study Minimal FU M15 (12)
    CL Item
    Post-Study Minimal FU M18 (13)
    CL Item
    Post-Study Minimal FU M21 (14)
    CL Item
    Post-Study Minimal FU M324 (15)
    CL Item
    Post-Study Minimal FU M___ (16)
    CL Item
    Post-Study Minimal FU M___ (17)
    Item
    Page Range
    text
    C3889409 (UMLS CUI [1,1])
    C1704732 (UMLS CUI [1,2])
    C1514721 (UMLS CUI [1,3])
    Clinical Trial Regulatory Tracking Document, Module
    Code List
    Page Range
    CL Item
    1-25 (1)
    CL Item
    26-27 (2)
    CL Item
    28-29 (3)
    CL Item
    30-31 (4)
    CL Item
    32-33 (5)
    CL Item
    34-35 (6)
    CL Item
    36 (7)
    CL Item
    1 page (8)
    CL Item
    1 page (9)
    CL Item
    1 page (10)
    CL Item
    1 page (11)
    CL Item
    1 page (12)
    CL Item
    1 page (13)
    CL Item
    1 page (14)
    CL Item
    1 page (15)
    CL Item
    1 page (16)
    CL Item
    1 page (17)
    Item
    Modules
    text
    C3889409 (UMLS CUI [1,1])
    C1709061 (UMLS CUI [1,2])
    C1519246 (UMLS CUI [1,3])
    Clinical Trial Regulatory Tracking Document, Module, Send
    Code List
    Modules
    CL Item
    Sent to DM (1)
    CL Item
    Unused (2)
    Clinical Trial Regulatory Tracking Document, Page, Missing
    Item
    Missing pages (if applicable)
    text
    C3889409 (UMLS CUI [1,1])
    C1704732 (UMLS CUI [1,2])
    C1705492 (UMLS CUI [1,3])
    Clinical Trial Regulatory Tracking Document, Comment
    Item
    Site Monitor's comments (e.g. protocol violations or deviations)
    text
    C3889409 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Clinical Trial Regulatory Tracking Document, Investigator Signature
    Item
    Site Monitor's signature
    text
    C3889409 (UMLS CUI [1,1])
    C2346576 (UMLS CUI [1,2])
    Clinical Trial Regulatory Tracking Document, Investigator Signature, Date in time
    Item
    Date Submitted
    date
    C3889409 (UMLS CUI [1,1])
    C2346576 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
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