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ID

6944

Descripción

E3A06 Source Document Tracking Coversheet Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=86D0D05F-CCF7-87DB-E040-BB89AD4374EF

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=86D0D05F-CCF7-87DB-E040-BB89AD4374EF

Palabras clave

Versiones (2)
  1. 19/9/12 19/9/12 -
  2. 8/1/15 8/1/15 - Martin Dugas
Subido en

8 de enero de 2015

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy
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    Multiple Myeloma and Plasma Cell Neoplasm NCT01169337 Transmittal - E3A06 Source Document Tracking Coversheet - 3086867v1.0

    Inglés

    No Instruction available.

    1 formularios  
    1. StudyEvent: E3A06 Source Document Tracking Coversheet
      1. No Instruction available.
    Header
    Descripción

    Header

    DCI Name
    Descripción

    Generic drug form

    Tipo de datos

    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 (Place ID Label Here)
    Descripción

    Registration Number

    Tipo de datos

    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
    Patient Initials (Last, First)
    Descripción

    Patient Initials

    Tipo de datos

    text

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

    Protocol Number ECOG

    Tipo de datos

    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 Protocol Number
    Descripción

    Protocol Number ECOG

    Tipo de datos

    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
    Descripción

    Patient ID ECOG

    Tipo de datos

    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
    ECOG Patient ID
    Descripción

    Patient ID ECOG

    Tipo de datos

    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
    Descripción

    Study Number Participating Group

    Tipo de datos

    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
    Descripción

    Trial subject ID Participating Group

    Tipo de datos

    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
    Descripción

    Institution Name

    Tipo de datos

    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
    On Treatment
    Descripción

    On Treatment

    On Treatment or Observation Report Period
    Descripción

    Cycle number

    Tipo de datos

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C2045829
    NCI Thesaurus Property
    C25214
    NCI Thesaurus Property-2
    C25616
    NCI Thesaurus ObjectClass
    C15368
    Specify Cycle
    Descripción

    Chemotherapy cycle

    Tipo de datos

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25214
    UMLS CUI-1
    C1302181
    NCI Thesaurus Property-2
    C25616
    NCI Thesaurus ValueDomain
    C25685
    NCI Thesaurus ValueDomain-2
    C25472
    NCI Thesaurus ValueDomain-3
    C25275
    Off Treatment
    Descripción

    Off Treatment

    Off Treatment or Off Observation Report Period (Choose one)
    Descripción

    PersonOff-TreatmentTimePeriodType

    Tipo de datos

    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
    Document Type
    Descripción

    Document Type

    Document type (Choose all that apply)
    Descripción

    ProtocolDocumentSubmittedType

    Tipo de datos

    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
    Lab, Hematology, Sample Collection Date
    Descripción

    HematologySpecimenCollectedDate

    Tipo de datos

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C16673
    UMLS 2011AA ObjectClass
    C0018943
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    NCI Thesaurus Property
    C25452
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    No Instruction available.

    1 formularios
    1. StudyEvent: E3A06 Source Document Tracking Coversheet
      1. No Instruction available.
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Header
    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 (Place ID Label Here)
    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)
    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)
    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)
    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)
    Item
    On Treatment or Observation Report Period
    text
    C25284 (NCI Thesaurus ValueDomain)
    C2045829 (UMLS CUI-1)
    C25214 (NCI Thesaurus Property)
    C25616 (NCI Thesaurus Property-2)
    C15368 (NCI Thesaurus ObjectClass)
    CL.1
    Code List
    On Treatment or Observation Report Period
    CL Item
    Baseline (baseline)
    C25213 (NCI Thesaurus)
    C1442488 (UMLS 2011AA)
    C25213 (NCI Thesaurus-3)
    C1442488 (UMLS 2011AA-4)
    CL Item
    Cycle 1 (Cycle 1)
    CL Item
    Cycle 2 (Cycle 2)
    CL Item
    Cycle 3 (Cycle 3)
    CL Item
    Cycle 4 (cycle 4)
    CL Item
    Cycle 5 (Cycle 5)
    CL Item
    Cycle 6 (Cycle 6)
    CL Item
    Cycle 7 (Cycle 7)
    CL Item
    Cycle 8 (cycle 8)
    CL Item
    Cycle 9 (Cycle 9)
    CL Item
    Cycle 10 (Cycle 10)
    CL Item
    Cycle 11 (Cycle 11)
    CL Item
    Cycle 12 (Cycle 12)
    CL Item
    Cycle 13 (Cycle 13)
    CL Item
    Cycle 14 (Cycle 14)
    CL Item
    Cycle 15 (Cycle 15)
    CL Item
    Cycle 16 (Cycle 16)
    CL Item
    Cycle 17 (Cycle 17)
    CL Item
    Cycle 18 (Cycle 18)
    CL Item
    Cycle 19 (Cycle 19)
    CL Item
    > Cycle 19 (> Cycle 19)
    Chemotherapy cycle
    Item
    Specify Cycle
    text
    C15368 (NCI Thesaurus ObjectClass)
    C25214 (NCI Thesaurus Property)
    C1302181 (UMLS CUI-1)
    C25616 (NCI Thesaurus Property-2)
    C25685 (NCI Thesaurus ValueDomain)
    C25472 (NCI Thesaurus ValueDomain-2)
    C25275 (NCI Thesaurus ValueDomain-3)
    Item
    Off Treatment or Off Observation 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.2
    Code List
    Off Treatment or Off Observation 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)
    Item Group
    Document Type
    Item
    Document type (Choose all that apply)
    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.3
    Code List
    Document type (Choose all that apply)
    CL Item
    Serum Protein Electrophoresis (Serum Protein Electrophoresis)
    CL Item
    Serum Free Light Chain Assay (Serum Free Light Chain assay)
    CL Item
    Serum Immunofixation (Serum Immunofixation)
    CL Item
    Serum Quantitative Immunoglobulins (Serum Quantitative Immunoglobulins)
    CL Item
    Urine Protein Electrophoresis (upep, 24hr) (Urine Protein Electrophoresis (UPEP, 24hr))
    CL Item
    Urine Immunofixation (Urine Immunofixation)
    CL Item
    Bone Marrow Biopsy And Aspirate (Bone Marrow Biopsy and Aspirate)
    CL Item
    Bone X-rays, Or Other Image Reports (Bone X-rays, or other image reports)
    CL Item
    Biopsy Reports For Any Soft Tissue Plasmacytoma (Biopsy Reports for any Soft Tissue Plasmacytoma)
    CL Item
    Peripheral Blood Chemistry (Peripheral Blood Chemistry)
    CL Item
    Patient Pill Diary (Patient pill diary)
    HematologySpecimenCollectedDate
    Item
    Lab, Hematology, Sample Collection Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C16673 (NCI Thesaurus ObjectClass)
    C0018943 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    C25452 (NCI Thesaurus Property)
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