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Southwest Oncology Group S0805 Registration Worksheet Form (Step 1) Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8FB90D5C-D5F7-9108-E040-BB89AD43238E

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8FB90D5C-D5F7-9108-E040-BB89AD43238E

Stichworte

  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

9. Januar 2015

DOI

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    Leukemia NCT00792948 Registration - Southwest Oncology Group S0805 Registration Worksheet Form (Step 1) - 3135175v1.0

    INSTRUCTIONS: All of the information on this Registration Worksheet and the Protocol Eligibility Section must be answered appropriately for a patient to be considered eligible for registration. This Registration Worksheet must be entirely filled out and referred to during the registration. Do NOT submit this worksheet as part of the patient data.

    Header
    Beschreibung

    Header

    Activation Date (MM DD YYYY)
    Beschreibung

    ClinicalStudyProtocolAmendmentActivationDate

    Datentyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C64382
    UMLS 2011AA Property
    C1879547
    NCI Thesaurus Property-2
    C41200
    UMLS 2011AA Property-2
    C0680532
    Last Amended Date (MM DD YYYY)
    Beschreibung

    DataAmendedLastDate

    Datentyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C25474
    UMLS 2011AA ObjectClass
    C1511726
    NCI Thesaurus Property
    C25416
    UMLS 2011AA Property
    C1691222
    NCI Thesaurus ValueDomain-2
    C25551
    UMLS 2011AA ValueDomain-2
    C1517741
    Registration Step
    Beschreibung

    Registration Number

    Datentyp

    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
    Swog Patient Id
    Beschreibung

    Swog Patient Id

    SWOG Patient ID Status
    Beschreibung

    PatientSouthwestOncologyGroupIdentifierStatus

    Datentyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property-2
    C25699
    UMLS 2011AA Property-2
    C1519429
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    SWOG Patient ID
    Beschreibung

    Trial subject ID SWOG

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1519429
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25699
    Demography
    Beschreibung

    Demography

    Patient First Name
    Beschreibung

    First Name

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1443235
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25509
    Patient Middle Name
    Beschreibung

    PatientMiddleName

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property-2
    C25569
    UMLS 2011AA Property-2
    C0444598
    Patient Last Name
    Beschreibung

    Last Name

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1301584
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25551
    Unnamed2
    Beschreibung

    Unnamed2

    Registrar's SWOG Roster ID Number
    Beschreibung

    RegistrarSouthwestOncologyGroupIdentifierNumber

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property-2
    C25699
    UMLS 2011AA Property-2
    C1519429
    NCI Thesaurus ObjectClass
    C25357
    UMLS 2011AA ObjectClass
    C0557514
    SWOG Investigator Number
    Beschreibung

    SouthwestOncologyGroupInvestigatorIdentifierNumber

    Datentyp

    float

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C25699
    UMLS 2011AA ObjectClass
    C1519429
    NCI Thesaurus ObjectClass-2
    C17089
    UMLS 2011AA ObjectClass-2
    C0035173
    SWOG Treating Institution Number
    Beschreibung

    SouthwestOncologyGroupTreatingInstitutionIdentifierNumber

    Datentyp

    float

    Alias
    NCI Thesaurus ObjectClass
    C25699
    UMLS 2011AA ObjectClass
    C1519429
    NCI Thesaurus ObjectClass-2
    C25705
    UMLS 2011AA ObjectClass-2
    C1522326
    NCI Thesaurus ObjectClass-3
    C41206
    UMLS 2011AA ObjectClass-3
    C1272753
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    Unnamed5
    Beschreibung

    Unnamed5

    Date Informed Consent Signed (MM DD YYYY)
    Beschreibung

    InformedConsentFormSignedDate

    Datentyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C16468
    UMLS 2011AA ObjectClass
    C0009797
    NCI Thesaurus Property
    C25679
    Date HIPAA Authorization signed (Not required if Country of Residence is not USA MM DD YYYY)
    Beschreibung

    HIPAA Approval Date

    Datentyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0600593
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C2346844
    NCI Thesaurus Property
    C25425
    Projected Start Date of Treatment (MM DD YYYY)
    Beschreibung

    Treatment Begin Date

    Datentyp

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C25631
    NCI Thesaurus Property
    C25431
    UMLS CUI-1
    C3173309
    NCI Thesaurus Property-2
    C25275
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25431
    Stratification Question
    Beschreibung

    Stratification Question

    Prior treatment and disease status
    Beschreibung

    SouthwestOncologyGroupPatientRegistrationEligibilityDeterminationS0805Type

    Datentyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C25699
    UMLS 2011AA ObjectClass-2
    C1519429
    NCI Thesaurus Property
    C25646
    UMLS 2011AA Property
    C1514821
    NCI Thesaurus Property-2
    C25171
    UMLS 2011AA Property-2
    C0013893
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Unnamed4
    Beschreibung

    Unnamed4

    My specimens may be kept for use in research to learn about, prevent, treat, or cure cancer.
    Beschreibung

    PersonSpecimenMalignantNeoplasmResearchConsentInd-2

    Datentyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property-2
    C9305
    UMLS 2011AA Property
    C0006826
    NCI Thesaurus Property-3
    C19157
    UMLS 2011AA Property-2
    C0370003
    NCI Thesaurus Property-4
    C25460
    UMLS 2011AA Property-3
    C1511481
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    My specimens may be kept for use in research about other health problems (for example: diabetes, Alzheimer's disease, or heart disease).
    Beschreibung

    PatientOtherDiseaseorDisorderClinicalStudyConsentInd-2

    Datentyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C17649
    UMLS 2011AA Property
    C0205394
    NCI Thesaurus Property-2
    C2991
    UMLS 2011AA Property-2
    C0012634
    NCI Thesaurus Property-3
    C15206
    UMLS 2011AA Property-3
    C0008972
    NCI Thesaurus Property-4
    C25460
    UMLS 2011AA Property-4
    C1511481
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Someone may contact me in the future to ask me to allow other uses of my specimens.
    Beschreibung

    Permission to contact Patient

    Datentyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-1
    C1522577
    NCI Thesaurus Property
    C67527
    UMLS CUI-2
    C0521104
    NCI Thesaurus Property-2
    C25460
    NCI Thesaurus Property-3
    C16452
    NCI Thesaurus ValueDomain
    C38148
    I agree to allow my study doctor, or someone approved by my study doctor, to contact me regarding future research involving my participation in this study
    Beschreibung

    SouthwestOncologyGroupPatientResearchConsentInd-2

    Datentyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C25699
    UMLS 2011AA ObjectClass-2
    C1519429
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property-2
    C25460
    UMLS 2011AA Property
    C1511481
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Unnamed 7
    Beschreibung

    Unnamed 7

    Has the Southwest Oncology Group Registration Worksheet been completed entirely and is the patient eligible according to the current version of protocol section 5.0
    Beschreibung

    SouthwestOncologyGroupPatientRegistrationEligibilityDeterminationInd-2

    Datentyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C25699
    UMLS 2011AA ObjectClass-2
    C1519429
    NCI Thesaurus Property
    C25646
    UMLS 2011AA Property
    C1514821
    NCI Thesaurus Property-2
    C25171
    UMLS 2011AA Property-2
    C0013893
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698

    Ähnliche Modelle

    INSTRUCTIONS: All of the information on this Registration Worksheet and the Protocol Eligibility Section must be answered appropriately for a patient to be considered eligible for registration. This Registration Worksheet must be entirely filled out and referred to during the registration. Do NOT submit this worksheet as part of the patient data.

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Header
    ClinicalStudyProtocolAmendmentActivationDate
    Item
    Activation Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C64382 (NCI Thesaurus Property)
    C1879547 (UMLS 2011AA Property)
    C41200 (NCI Thesaurus Property-2)
    C0680532 (UMLS 2011AA Property-2)
    DataAmendedLastDate
    Item
    Last Amended Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25474 (NCI Thesaurus ObjectClass)
    C1511726 (UMLS 2011AA ObjectClass)
    C25416 (NCI Thesaurus Property)
    C1691222 (UMLS 2011AA Property)
    C25551 (NCI Thesaurus ValueDomain-2)
    C1517741 (UMLS 2011AA ValueDomain-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 Group
    Swog Patient Id
    Item
    SWOG Patient ID Status
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25699 (NCI Thesaurus Property-2)
    C1519429 (UMLS 2011AA Property-2)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    Code List
    SWOG Patient ID Status
    CL Item
    New Patient (New patient)
    CL Item
    Previous Patient (Previous patient)
    Trial subject ID SWOG
    Item
    SWOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1519429 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25699 (NCI Thesaurus Property-2)
    Item Group
    Demography
    First Name
    Item
    Patient First Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1443235 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    C25509 (NCI Thesaurus Property-2)
    PatientMiddleName
    Item
    Patient Middle Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25569 (NCI Thesaurus Property-2)
    C0444598 (UMLS 2011AA Property-2)
    Last Name
    Item
    Patient Last Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1301584 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    C25551 (NCI Thesaurus Property-2)
    Item Group
    Unnamed2
    RegistrarSouthwestOncologyGroupIdentifierNumber
    Item
    Registrar's SWOG Roster ID Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25699 (NCI Thesaurus Property-2)
    C1519429 (UMLS 2011AA Property-2)
    C25357 (NCI Thesaurus ObjectClass)
    C0557514 (UMLS 2011AA ObjectClass)
    SouthwestOncologyGroupInvestigatorIdentifierNumber
    Item
    SWOG Investigator Number
    float
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25699 (NCI Thesaurus ObjectClass)
    C1519429 (UMLS 2011AA ObjectClass)
    C17089 (NCI Thesaurus ObjectClass-2)
    C0035173 (UMLS 2011AA ObjectClass-2)
    SouthwestOncologyGroupTreatingInstitutionIdentifierNumber
    Item
    SWOG Treating Institution Number
    float
    C25699 (NCI Thesaurus ObjectClass)
    C1519429 (UMLS 2011AA ObjectClass)
    C25705 (NCI Thesaurus ObjectClass-2)
    C1522326 (UMLS 2011AA ObjectClass-2)
    C41206 (NCI Thesaurus ObjectClass-3)
    C1272753 (UMLS 2011AA ObjectClass-3)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    Item Group
    Unnamed5
    InformedConsentFormSignedDate
    Item
    Date Informed Consent Signed (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    C16468 (NCI Thesaurus ObjectClass)
    C0009797 (UMLS 2011AA ObjectClass)
    C25679 (NCI Thesaurus Property)
    HIPAA Approval Date
    Item
    Date HIPAA Authorization signed (Not required if Country of Residence is not USA MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0600593 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C2346844 (UMLS CUI-2)
    C25425 (NCI Thesaurus Property)
    Treatment Begin Date
    Item
    Projected Start Date of Treatment (MM DD YYYY)
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25631 (NCI Thesaurus ObjectClass-2)
    C25431 (NCI Thesaurus Property)
    C3173309 (UMLS CUI-1)
    C25275 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    Item Group
    Stratification Question
    Item
    Prior treatment and disease status
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25699 (NCI Thesaurus ObjectClass-2)
    C1519429 (UMLS 2011AA ObjectClass-2)
    C25646 (NCI Thesaurus Property)
    C1514821 (UMLS 2011AA Property)
    C25171 (NCI Thesaurus Property-2)
    C0013893 (UMLS 2011AA Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    Code List
    Prior treatment and disease status
    CL Item
    Previously Untreated (1)
    CL Item
    Achieved Remission (cr Or Cri) (2)
    CL Item
    Refractory (previously Treated But Did Not Achieve Cr Or Cri) (3)
    PersonSpecimenMalignantNeoplasmResearchConsentInd-2
    Item
    My specimens may be kept for use in research to learn about, prevent, treat, or cure cancer.
    boolean
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C15319 (NCI Thesaurus Property)
    C9305 (NCI Thesaurus Property-2)
    C0006826 (UMLS 2011AA Property)
    C19157 (NCI Thesaurus Property-3)
    C0370003 (UMLS 2011AA Property-2)
    C25460 (NCI Thesaurus Property-4)
    C1511481 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    PatientOtherDiseaseorDisorderClinicalStudyConsentInd-2
    Item
    My specimens may be kept for use in research about other health problems (for example: diabetes, Alzheimer's disease, or heart disease).
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C17649 (NCI Thesaurus Property)
    C0205394 (UMLS 2011AA Property)
    C2991 (NCI Thesaurus Property-2)
    C0012634 (UMLS 2011AA Property-2)
    C15206 (NCI Thesaurus Property-3)
    C0008972 (UMLS 2011AA Property-3)
    C25460 (NCI Thesaurus Property-4)
    C1511481 (UMLS 2011AA Property-4)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Permission to contact Patient
    Item
    Someone may contact me in the future to ask me to allow other uses of my specimens.
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C1522577 (UMLS CUI-1)
    C67527 (NCI Thesaurus Property)
    C0521104 (UMLS CUI-2)
    C25460 (NCI Thesaurus Property-2)
    C16452 (NCI Thesaurus Property-3)
    C38148 (NCI Thesaurus ValueDomain)
    SouthwestOncologyGroupPatientResearchConsentInd-2
    Item
    I agree to allow my study doctor, or someone approved by my study doctor, to contact me regarding future research involving my participation in this study
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25699 (NCI Thesaurus ObjectClass-2)
    C1519429 (UMLS 2011AA ObjectClass-2)
    C15319 (NCI Thesaurus Property)
    C25460 (NCI Thesaurus Property-2)
    C1511481 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Item Group
    Unnamed 7
    SouthwestOncologyGroupPatientRegistrationEligibilityDeterminationInd-2
    Item
    Has the Southwest Oncology Group Registration Worksheet been completed entirely and is the patient eligible according to the current version of protocol section 5.0
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25699 (NCI Thesaurus ObjectClass-2)
    C1519429 (UMLS 2011AA ObjectClass-2)
    C25646 (NCI Thesaurus Property)
    C1514821 (UMLS 2011AA Property)
    C25171 (NCI Thesaurus Property-2)
    C0013893 (UMLS 2011AA Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)

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