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ID

12599

Description

N0874 Pre-Registration (Step 1) Eligibility Checklist Vorinostat, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7F194A19-97CE-83E0-E040-BB89AD431393

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7F194A19-97CE-83E0-E040-BB89AD431393

Mots-clés

  1. 28/07/2015 28/07/2015 - Julian Varghese
  2. 28/07/2015 28/07/2015 - Julian Varghese
  3. 04/12/2015 04/12/2015 - Julian Varghese
  4. 17/09/2021 17/09/2021 -
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4 décembre 2015

DOI

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Creative Commons BY-NC 3.0

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    Glioblastoma multiforme N0874

    Phase I NCCTG Only (Limited to Mayo Rochester, Florida, and Arizona): Prior to discussing protocol entry with the patient, call the NCCTG Registration Office (507/284-4130) for dose level and to insure that a place on the protocol is open to the patient. To register a patient fax (507/284-0885) a completed eligibility checklist to the Registration Office between 8 a.m. and 4:30 p.m. Central time Monday through Friday. Phase II: All site staff (NCCTG and ABTC sites) will use the Oncology Patient Enrollment Network (OPEN) to enroll patients to each step of this study. OPEN can be accessed at https://open.ctsu.org or from the OPEN tab on the CTSU members' side of the website at https://www.ctsu.org

    Header
    Description

    Header

    Pre-Registration date
    Description

    PatientPriorRegistrationDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25646
    UMLS 2011AA Property
    C1514821
    NCI Thesaurus Property-2
    C25629
    UMLS 2011AA Property-2
    C0332152
    NCCTG Patient ID
    Description

    PatientNorthCentralCancerTreatmentGroupIdentifierNumber

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property-2
    C25581
    UMLS 2011AA Property-2
    C1518419
    Participating Group Code (participant sponsor)
    Description

    ParticipatingGroupIdentifierCode

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus ObjectClass
    C25608
    UMLS 2011AA ObjectClass
    C0679823
    NCI Thesaurus ObjectClass-2
    C17005
    UMLS 2011AA ObjectClass-2
    C1257890
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Institution (treating location)
    Description

    Institution Name

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    NCI Thesaurus ValueDomain-2
    C21541
    NCI Thesaurus Property
    C25364
    Physician of Record
    Description

    Investigator Name

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2826892
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ObjectClass
    C17089
    NCI Thesaurus ObjectClass-2
    C25644
    Patient Medical Record Number
    Description

    Medical Record Number

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301894
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25261
    NCI Thesaurus Property-2
    C25198
    Last name
    Description

    Person Completing Form Last Name

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass-2
    C25657
    UMLS CUI-2
    C1301584
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25551
    NCI Thesaurus ValueDomain
    C25191
    First Name
    Description

    Person Completing Form First Name

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass-2
    C25657
    UMLS CUI-2
    C1443235
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25509
    NCI Thesaurus ValueDomain
    C25191
    Phone
    Description

    Person Completing Form Phone

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass
    C25190
    UMLS CUI-2
    C1515258
    NCI Thesaurus ObjectClass-2
    C25657
    NCI Thesaurus Property
    C25395
    Fax
    Description

    ResponsiblePersonFaxNumber

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ObjectClass-2
    C25657
    UMLS 2011AA ObjectClass-2
    C1273518
    NCI Thesaurus Property
    C25210
    UMLS 2011AA Property
    C0085205
    E-mail
    Description

    ResponsiblePersonE-mailAddressText

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C25657
    UMLS 2011AA ObjectClass
    C1273518
    NCI Thesaurus Property
    C42775
    UMLS 2011AA Property
    C1705961
    Patient Demographics / Pre-treatment Characteristics
    Description

    Patient Demographics / Pre-treatment Characteristics

    Alias
    UMLS CUI-1
    C1704791
    Patient Initials
    Description

    Patient Initials

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Gender
    Description

    Gender

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS CUI-1
    C0079399
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C17357
    Date of Birth
    Description

    PersonBirthDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25155
    UMLS 2011AA Property
    C0005615
    Zip code
    Description

    PersonAddressPostalCode

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25407
    UMLS 2011AA Property
    C1442065
    Country of Residence
    Description

    PersonAddressCountryName

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ValueDomain
    C25464
    UMLS 2011AA ValueDomain
    C0454664
    NCI Thesaurus Property
    C25407
    UMLS 2011AA Property
    C1442065
    NCI Thesaurus ValueDomain-2
    C42614
    UMLS 2011AA ValueDomain-2
    C0027365
    Method of Payment (check oneUSA only)
    Description

    PatientPaymentType

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25371
    UMLS 2011AA Property
    C0680264
    Race
    Description

    Racial Group

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS CUI-1
    C0034510
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C17049
    Ethnicity
    Description

    Ethnic Group

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS CUI-1
    C0015031
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C16564
    Intensity modulated radiation therapy
    Description

    Intensity modulated radiation therapy

    Alias
    UMLS CUI-1
    C1512814
    Is your site using IMRT for this study?
    Description

    IMRT usage

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    NCI Thesaurus Property
    C16135
    NCI Thesaurus ObjectClass
    C41206
    NCI Thesaurus Property-2
    C25409
    UMLS CUI-1
    C1512814
    If yes, is your site certified?
    Description

    IMRT Certification

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    NCI Thesaurus Property
    C16135
    NCI Thesaurus ObjectClass
    C41206
    NCI Thesaurus Property-2
    C43610
    UMLS CUI-1
    C1512814
    UMLS CUI-2
    C0007836
    Neurocognitive Testing Certification
    Description

    Neurocognitive Testing Certification

    Is at least one individual at your site certified for Neurocognitive testing
    Description

    Person certified for neurocognitive testing

    Type de données

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25190
    NCI Thesaurus Property
    C81313
    NCI Thesaurus Property-2
    C41206
    NCI Thesaurus Property-3
    C73925
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0027361
    UMLS CUI-2
    C0027853
    UMLS CUI-3
    C1272753
    UMLS CUI-4
    C2362313
    Eligibility Check
    Description

    Eligibility Check

    Central pathology review submission. This review is mandatory prior to registration to confirm eligibility. It should be initiated as soon after surgery as possible.
    Description

    PathologySpecimenCentralReviewerSubmissionInd-2

    Type de données

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus ObjectClass-2
    C18189
    UMLS 2011AA ObjectClass-2
    C0030664
    NCI Thesaurus Property
    C25694
    UMLS 2011AA Property
    C1515022
    NCI Thesaurus Property-2
    C51807
    UMLS 2011AA Property-2
    C1707338
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Treatment should begin >=2 weeks and <=5 weeks following surgery
    Description

    TherapyBeginRequirementInd-2

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25431
    UMLS 2011AA Property
    C0439659
    NCI Thesaurus Property-2
    C38015
    Pre-registration Check
    Description

    Pre-registration Check

    Consent form signed and dated
    Description

    InformedConsentFormSignedInd-2

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C16468
    UMLS 2011AA ObjectClass
    C0009797
    NCI Thesaurus Property
    C25679
    Date Informed Consent Signed
    Description

    InformedConsentFormSignedDate

    Type de données

    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
    Authorization for use and disclosure of protected health information signed and dated (If not a USA institution check NA)
    Description

    PatientHealthRecordIndicator

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25178
    UMLS 2011AA Property
    C0018684
    Date of authorization (If a USA institution)
    Description

    HealthInsurancePortabilityandAccountabilityActTissueDonorAuthorizationDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25168
    UMLS 2011AA Property
    C0040288
    NCI Thesaurus ObjectClass
    C62504
    UMLS 2011AA ObjectClass
    C0600593
    NCI Thesaurus Property-2
    C41192
    UMLS 2011AA Property-2
    C1524004
    The site has reviewed and understands the process listed in Section 17.0 and must account for sufficient time to complete pre-registration and registration steps
    Description

    CentralPathologyReviewPriorRandomizationRequirementInd-2

    Type de données

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C71684
    UMLS 2011AA ObjectClass
    C2347585
    NCI Thesaurus Property
    C25196
    UMLS 2011AA Property
    C0034656
    NCI Thesaurus Property-2
    C25629
    UMLS 2011AA Property-2
    C0332152
    NCI Thesaurus Property-3
    C25652
    UMLS 2011AA Property-3
    C1514873
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    An NCCTG or ABTC approved radiation oncologist has seen the patient and confirms the patient is a suitable candidate for this study
    Description

    Radiation oncologist confirmed patient eligibility

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25171
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C0013893

    Similar models

    Phase I NCCTG Only (Limited to Mayo Rochester, Florida, and Arizona): Prior to discussing protocol entry with the patient, call the NCCTG Registration Office (507/284-4130) for dose level and to insure that a place on the protocol is open to the patient. To register a patient fax (507/284-0885) a completed eligibility checklist to the Registration Office between 8 a.m. and 4:30 p.m. Central time Monday through Friday. Phase II: All site staff (NCCTG and ABTC sites) will use the Oncology Patient Enrollment Network (OPEN) to enroll patients to each step of this study. OPEN can be accessed at https://open.ctsu.org or from the OPEN tab on the CTSU members' side of the website at https://www.ctsu.org

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Header
    PatientPriorRegistrationDate
    Item
    Pre-Registration date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25646 (NCI Thesaurus Property)
    C1514821 (UMLS 2011AA Property)
    C25629 (NCI Thesaurus Property-2)
    C0332152 (UMLS 2011AA Property-2)
    PatientNorthCentralCancerTreatmentGroupIdentifierNumber
    Item
    NCCTG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25581 (NCI Thesaurus Property-2)
    C1518419 (UMLS 2011AA Property-2)
    ParticipatingGroupIdentifierCode
    Item
    Participating Group Code (participant sponsor)
    text
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25608 (NCI Thesaurus ObjectClass)
    C0679823 (UMLS 2011AA ObjectClass)
    C17005 (NCI Thesaurus ObjectClass-2)
    C1257890 (UMLS 2011AA ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    Institution Name
    Item
    Institution (treating location)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C21541 (NCI Thesaurus ValueDomain-2)
    C25364 (NCI Thesaurus Property)
    Investigator Name
    Item
    Physician of Record
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2826892 (UMLS CUI-1)
    C25364 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    C25644 (NCI Thesaurus ObjectClass-2)
    Medical Record Number
    Item
    Patient Medical Record Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301894 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25261 (NCI Thesaurus Property)
    C25198 (NCI Thesaurus Property-2)
    Person Completing Form Last Name
    Item
    Last name
    text
    C25190 (NCI Thesaurus ObjectClass)
    C1550483 (UMLS CUI-1)
    C25657 (NCI Thesaurus ObjectClass-2)
    C1301584 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25551 (NCI Thesaurus Property-2)
    C25191 (NCI Thesaurus ValueDomain)
    Person Completing Form First Name
    Item
    First Name
    text
    C25190 (NCI Thesaurus ObjectClass)
    C1550483 (UMLS CUI-1)
    C25657 (NCI Thesaurus ObjectClass-2)
    C1443235 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25509 (NCI Thesaurus Property-2)
    C25191 (NCI Thesaurus ValueDomain)
    Person Completing Form Phone
    Item
    Phone
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1550483 (UMLS CUI-1)
    C25190 (NCI Thesaurus ObjectClass)
    C1515258 (UMLS CUI-2)
    C25657 (NCI Thesaurus ObjectClass-2)
    C25395 (NCI Thesaurus Property)
    ResponsiblePersonFaxNumber
    Item
    Fax
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25657 (NCI Thesaurus ObjectClass-2)
    C1273518 (UMLS 2011AA ObjectClass-2)
    C25210 (NCI Thesaurus Property)
    C0085205 (UMLS 2011AA Property)
    ResponsiblePersonE-mailAddressText
    Item
    E-mail
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25657 (NCI Thesaurus ObjectClass)
    C1273518 (UMLS 2011AA ObjectClass)
    C42775 (NCI Thesaurus Property)
    C1705961 (UMLS 2011AA Property)
    Item Group
    Patient Demographics / Pre-treatment Characteristics
    C1704791 (UMLS CUI-1)
    Patient Initials
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Item
    Gender
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0079399 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C17357 (NCI Thesaurus Property)
    Code List
    Gender
    CL Item
    Male (MALE)
    C46109 (NCI Thesaurus)
    C1706180 (UMLS 2011AA)
    CL Item
    Female (FEMALE)
    C46110 (NCI Thesaurus)
    C0015780 (UMLS 2011AA)
    CL Item
    Unknown (UNKNOWN)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    PersonBirthDate
    Item
    Date of Birth
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25155 (NCI Thesaurus Property)
    C0005615 (UMLS 2011AA Property)
    PersonAddressPostalCode
    Item
    Zip code
    text
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25407 (NCI Thesaurus Property)
    C1442065 (UMLS 2011AA Property)
    PersonAddressCountryName
    Item
    Country of Residence
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25464 (NCI Thesaurus ValueDomain)
    C0454664 (UMLS 2011AA ValueDomain)
    C25407 (NCI Thesaurus Property)
    C1442065 (UMLS 2011AA Property)
    C42614 (NCI Thesaurus ValueDomain-2)
    C0027365 (UMLS 2011AA ValueDomain-2)
    Item
    Method of Payment (check oneUSA only)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25371 (NCI Thesaurus Property)
    C0680264 (UMLS 2011AA Property)
    Code List
    Method of Payment (check oneUSA only)
    CL Item
    Private Insurance (Private Insurance)
    CL Item
    Medicare (Medicare)
    C16665 (NCI Thesaurus)
    C0018717 (UMLS 2011AA)
    CL Item
    Medicare And Private Insurance (Medicare and Private Insurance)
    CL Item
    Medicaid (Medicaid)
    C0025071 (NCI Metathesaurus)
    CL Item
    Medicaid And Medicare (Medicaid and Medicare)
    CL Item
    Military Or Veterans Sponsored Nos (Military or Veterans Sponsored, Not Otherwise Specified (NOS))
    CL Item
    Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & TRICARE))
    CL Item
    Veterans Sponsored (Veterans Sponsored)
    CL Item
    Self Pay (no Insurance) (Self Pay (No Insurance))
    CL Item
    No Means Of Payment (no Insurance) (No means of payment (no insurance))
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Race
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0034510 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C17049 (NCI Thesaurus Property)
    Code List
    Race
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)
    C41261 (NCI Thesaurus)
    C0007457 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)
    C16352 (NCI Thesaurus)
    C0085756 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)
    C41219 (NCI Thesaurus)
    C1513907 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
    C41260 (NCI Thesaurus)
    C0078988 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)
    C41259 (NCI Thesaurus)
    C1515945 (UMLS 2011AA)
    CL Item
    Not Provided Or Available (Not Reported)
    C43234 (NCI Thesaurus)
    C1706613 (UMLS 2011AA)
    CL Item
    Could Not Be Determined Or Unsure (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Ethnicity
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0015031 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C16564 (NCI Thesaurus Property)
    Code List
    Ethnicity
    CL Item
    A Person Not Meeting The Definition For Hispanic Or Latino. (NOT HISPANIC OR LATINO)
    C41222 (NCI Thesaurus)
    C1518424 (UMLS 2011AA)
    CL Item
    A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (HISPANIC OR LATINO)
    C17459 (NCI Thesaurus)
    C0086409 (UMLS 2011AA)
    CL Item
    Not Provided Or Available (Not reported)
    C43234 (NCI Thesaurus)
    C1706613 (UMLS 2011AA)
    CL Item
    Could Not Be Determined Or Unsure (UNKNOWN)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item Group
    Intensity modulated radiation therapy
    C1512814 (UMLS CUI-1)
    IMRT usage
    Item
    Is your site using IMRT for this study?
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C16135 (NCI Thesaurus Property)
    C41206 (NCI Thesaurus ObjectClass)
    C25409 (NCI Thesaurus Property-2)
    C1512814 (UMLS CUI-1)
    IMRT Certification
    Item
    If yes, is your site certified?
    text
    C38148 (NCI Thesaurus ValueDomain)
    C16135 (NCI Thesaurus Property)
    C41206 (NCI Thesaurus ObjectClass)
    C43610 (NCI Thesaurus Property-2)
    C1512814 (UMLS CUI-1)
    C0007836 (UMLS CUI-2)
    Item Group
    Neurocognitive Testing Certification
    Person certified for neurocognitive testing
    Item
    Is at least one individual at your site certified for Neurocognitive testing
    boolean
    C25190 (NCI Thesaurus ObjectClass)
    C81313 (NCI Thesaurus Property)
    C41206 (NCI Thesaurus Property-2)
    C73925 (NCI Thesaurus Property-3)
    C38148 (NCI Thesaurus ValueDomain)
    C0027361 (UMLS CUI-1)
    C0027853 (UMLS CUI-2)
    C1272753 (UMLS CUI-3)
    C2362313 (UMLS CUI-4)
    Item Group
    Eligibility Check
    PathologySpecimenCentralReviewerSubmissionInd-2
    Item
    Central pathology review submission. This review is mandatory prior to registration to confirm eligibility. It should be initiated as soon after surgery as possible.
    boolean
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C18189 (NCI Thesaurus ObjectClass-2)
    C0030664 (UMLS 2011AA ObjectClass-2)
    C25694 (NCI Thesaurus Property)
    C1515022 (UMLS 2011AA Property)
    C51807 (NCI Thesaurus Property-2)
    C1707338 (UMLS 2011AA Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    TherapyBeginRequirementInd-2
    Item
    Treatment should begin >=2 weeks and <=5 weeks following surgery
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C25431 (NCI Thesaurus Property)
    C0439659 (UMLS 2011AA Property)
    C38015 (NCI Thesaurus Property-2)
    Item Group
    Pre-registration Check
    InformedConsentFormSignedInd-2
    Item
    Consent form signed and dated
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C16468 (NCI Thesaurus ObjectClass)
    C0009797 (UMLS 2011AA ObjectClass)
    C25679 (NCI Thesaurus Property)
    InformedConsentFormSignedDate
    Item
    Date Informed Consent Signed
    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)
    Item
    Authorization for use and disclosure of protected health information signed and dated (If not a USA institution check NA)
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25178 (NCI Thesaurus Property)
    C0018684 (UMLS 2011AA Property)
    Code List
    Authorization for use and disclosure of protected health information signed and dated (If not a USA institution check NA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Not Applicable (NA)
    C48660 (NCI Thesaurus)
    C1272460 (UMLS 2011AA)
    C48660 (NCI Thesaurus-3)
    C1272460 (UMLS 2011AA-4)
    HealthInsurancePortabilityandAccountabilityActTissueDonorAuthorizationDate
    Item
    Date of authorization (If a USA institution)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25168 (NCI Thesaurus Property)
    C0040288 (UMLS 2011AA Property)
    C62504 (NCI Thesaurus ObjectClass)
    C0600593 (UMLS 2011AA ObjectClass)
    C41192 (NCI Thesaurus Property-2)
    C1524004 (UMLS 2011AA Property-2)
    CentralPathologyReviewPriorRandomizationRequirementInd-2
    Item
    The site has reviewed and understands the process listed in Section 17.0 and must account for sufficient time to complete pre-registration and registration steps
    boolean
    C71684 (NCI Thesaurus ObjectClass)
    C2347585 (UMLS 2011AA ObjectClass)
    C25196 (NCI Thesaurus Property)
    C0034656 (UMLS 2011AA Property)
    C25629 (NCI Thesaurus Property-2)
    C0332152 (UMLS 2011AA Property-2)
    C25652 (NCI Thesaurus Property-3)
    C1514873 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Radiation oncologist confirmed patient eligibility
    Item
    An NCCTG or ABTC approved radiation oncologist has seen the patient and confirms the patient is a suitable candidate for this study
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25171 (NCI Thesaurus Property)
    C0030705 (UMLS CUI [1,1])
    C0013893 (UMLS CUI [1,2])

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