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ID

10796

Description

E1609 Source Document Tracking Coversheet NCT01274338 Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III or Stage IV Melanoma That Has Been Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9774BC47-50B5-931D-E040-BB89AD43322B

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9774BC47-50B5-931D-E040-BB89AD43322B

Keywords

Versions (3)
  1. 4/19/12 4/19/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 6/8/15 6/8/15 -
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June 8, 2015

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Creative Commons BY-NC 3.0 Legacy
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    E1609 Source Document Tracking Coversheet NCT01274338

    German English

    INSTRUCTIONS: Complete this form and attach to any source document to be submitted to ECOG. Submit original to the ECOG Coordinating Center. Keep a copy for your files. NOTE: Attach ALL of the source documents for each report period to ONE source document coversheet. Complete only one source document tracking coversheet for each of the report periods listed.

    1 forms  
    ECOG clinical trial administrative data
    Description

    ECOG clinical trial administrative data

    Patient Initials (Last, First)
    Description

    Patient Initials

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    ECOG Protocol Number
    Description

    Protocol Number ECOG

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    ECOG Patient ID
    Description

    Patient ID ECOG

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    Participating Group Protocol Number
    Description

    Study Number Participating Group

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Participating Group Patient ID
    Description

    Trial subject ID Participating Group

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Institution/Affiliate
    Description

    Institution Name

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass-2
    C21541
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ValueDomain
    C25191
    NCI Thesaurus ValueDomain-2
    C21541
    DCI Name
    Description

    Generic drug form

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C3242750
    NCI Thesaurus Property
    C19464
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus ObjectClass-2
    C25452
    Registration Step
    Description

    Registration Number

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1514821
    NCI Thesaurus ObjectClass
    C25646
    UMLS CUI-2
    C0237753
    NCI Thesaurus Property
    C16154
    NCI Thesaurus ValueDomain-2
    C16154
    On Treatment Reporting Period (Arm B only)
    Description

    Cycle number

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C2045829
    NCI Thesaurus Property
    C25214
    NCI Thesaurus Property-2
    C25616
    NCI Thesaurus ObjectClass
    C15368
    On Treatment Reporting Period
    Description

    On Treatment Reporting Period

    Off Treatment
    Description

    Off Treatment

    Off Treatment Report Period (Choose one)
    Description

    PersonOff-TreatmentTimePeriodType

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25616
    UMLS 2011AA Property
    C1948053
    NCI Thesaurus Property-2
    C25601
    UMLS 2011AA Property-2
    C1518544
    NCI Thesaurus Property-3
    C25207
    UMLS 2011AA Property-3
    C0040223
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Section II
    Description

    Section II

    Document type
    Description

    ProtocolDocumentSubmittedType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C42651
    UMLS 2011AA ObjectClass
    C0442711
    NCI Thesaurus ObjectClass-2
    C19498
    UMLS 2011AA ObjectClass-2
    C1547673
    NCI Thesaurus Property
    C25695
    UMLS 2011AA Property
    C1515023
    Report Created Date
    Description

    ReportCreatedDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C25375
    UMLS 2011AA ObjectClass
    C0684224
    NCI Thesaurus Property
    C42620
    UMLS 2011AA Property
    C1706214
    Back to the top of the page

    Similar models

    INSTRUCTIONS: Complete this form and attach to any source document to be submitted to ECOG. Submit original to the ECOG Coordinating Center. Keep a copy for your files. NOTE: Attach ALL of the source documents for each report period to ONE source document coversheet. Complete only one source document tracking coversheet for each of the report periods listed.

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    ECOG clinical trial administrative data
    Patient Initials
    Item
    Patient Initials (Last, First)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Protocol Number ECOG
    Item
    ECOG Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Patient ID ECOG
    Item
    ECOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Study Number Participating Group
    Item
    Participating Group Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Trial subject ID Participating Group
    Item
    Participating Group Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Institution Name
    Item
    Institution/Affiliate
    text
    C25454 (NCI Thesaurus ObjectClass)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C25191 (NCI Thesaurus ValueDomain)
    C21541 (NCI Thesaurus ValueDomain-2)
    Generic drug form
    Item
    DCI Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C3242750 (UMLS CUI-1)
    C19464 (NCI Thesaurus Property)
    C25474 (NCI Thesaurus ObjectClass)
    C25452 (NCI Thesaurus ObjectClass-2)
    Registration Number
    Item
    Registration Step
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1514821 (UMLS CUI-1)
    C25646 (NCI Thesaurus ObjectClass)
    C0237753 (UMLS CUI-2)
    C16154 (NCI Thesaurus Property)
    C16154 (NCI Thesaurus ValueDomain-2)
    Item
    On Treatment Reporting Period (Arm B only)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C2045829 (UMLS CUI-1)
    C25214 (NCI Thesaurus Property)
    C25616 (NCI Thesaurus Property-2)
    C15368 (NCI Thesaurus ObjectClass)
    CL.2
    Code List
    On Treatment Reporting Period (Arm B only)
    CL Item
    Week 5 (Week 5)
    CL Item
    Week 9 (Week 9)
    CL Item
    Week 13 (Week 13)
    CL Item
    Week 19 (Week 19)
    CL Item
    Week 25 (Week 25)
    CL Item
    Week 31 (Week 31)
    CL Item
    Week 37 (Week 37)
    CL Item
    Week 43 (Week 43)
    CL Item
    Week 49 (Week 49)
    Item Group
    On Treatment Reporting Period
    Item Group
    Off Treatment
    Item
    Off Treatment Report Period (Choose one)
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25616 (NCI Thesaurus Property)
    C1948053 (UMLS 2011AA Property)
    C25601 (NCI Thesaurus Property-2)
    C1518544 (UMLS 2011AA Property-2)
    C25207 (NCI Thesaurus Property-3)
    C0040223 (UMLS 2011AA Property-3)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.3
    Code List
    Off Treatment Report Period (Choose one)
    CL Item
    3 Months (3 Months Post Registration)
    CL Item
    6 Months (6 Months Post Registration)
    CL Item
    9 Months (9 Months Post Registration)
    CL Item
    12 Months (12 Months Post Registration)
    CL Item
    15 Months (15 Months Post Registration)
    CL Item
    18 Months (18 Months Post Registration)
    CL Item
    21 Months Post Registration (21 Months Post Registration)
    CL Item
    2 Years (24 Months Post Registration)
    CL Item
    30 Months (30 Months Post Registration)
    CL Item
    3 Years (36 Months Post Registration)
    CL Item
    42 Months (42 Months Post Registration)
    CL Item
    4 Years (48 Months Post Registration)
    CL Item
    54 Months (54 Months Post Registration)
    CL Item
    5 Years (60 Months Post Registration)
    CL Item
    6 Years (72 Months Post Registration)
    CL Item
    84 Months Post Registration (84 Months Post Registration)
    CL Item
    8 Years (96 months post registration)
    CL Item
    9 Years (108 months post registration)
    CL Item
    10 Years (120 months post registration)
    CL Item
    11 Years Post Registration (132 Months Post Registration)
    CL Item
    12 Years Post Registration (144 Months Post Registration)
    CL Item
    13 Years Post Registration (156 Months Post Registration)
    CL Item
    14 Years Post Registration (168 Months Post Registration)
    CL Item
    15 Years Post Registration (180 Months Post Registration)
    CL Item
    16 Years Post Registration (192 Months Post Registration)
    CL Item
    17 Years Post Registration (204 Months Post Registration)
    CL Item
    18 Years Post Registration (216 Months Post Registration)
    CL Item
    19 Years Post Registration (228 Months Post Registration)
    CL Item
    20 Years Post Registration (240 Months Post Registration)
    Item Group
    Section II
    Item
    Document type
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C42651 (NCI Thesaurus ObjectClass)
    C0442711 (UMLS 2011AA ObjectClass)
    C19498 (NCI Thesaurus ObjectClass-2)
    C1547673 (UMLS 2011AA ObjectClass-2)
    C25695 (NCI Thesaurus Property)
    C1515023 (UMLS 2011AA Property)
    CL.4
    Code List
    Document type
    CL Item
    Pathology Report (Pathology Report)
    C28277 (NCI Thesaurus)
    C0807321 (UMLS 2011AA)
    CL Item
    Surgical Report (Surgical Report)
    CL Item
    Patient Interferon Diary (Patient Interferon Diary)
    CL Item
    Braf Mutation (BRAF mutation)
    ReportCreatedDate
    Item
    Report Created Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25375 (NCI Thesaurus ObjectClass)
    C0684224 (UMLS 2011AA ObjectClass)
    C42620 (NCI Thesaurus Property)
    C1706214 (UMLS 2011AA Property)
    Back to the top of the page 

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