ID

42750

Beschrijving

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

Link

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

Trefwoorden

Versies (4)
  1. 28-07-15 28-07-15 - Julian Varghese
  2. 28-07-15 28-07-15 - Julian Varghese
  3. 04-12-15 04-12-15 - Julian Varghese
  4. 17-09-21 17-09-21 -
Geüploaded op

17 september 2021

DOI

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Licentie

Creative Commons BY-NC 3.0
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Glioblastoma multiforme N0874

Engels

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

1 Formulieren  
Header
Beschrijving

Header

Pre-Registration date
Beschrijving

PatientPriorRegistrationDate

Datatype

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
Beschrijving

PatientNorthCentralCancerTreatmentGroupIdentifierNumber

Datatype

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)
Beschrijving

ParticipatingGroupIdentifierCode

Datatype

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)
Beschrijving

Institution Name

Datatype

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
Beschrijving

Investigator Name

Datatype

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
Beschrijving

Medical Record Number

Datatype

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
Beschrijving

Person Completing Form Last Name

Datatype

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
Beschrijving

Person Completing Form First Name

Datatype

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
Beschrijving

Person Completing Form Phone

Datatype

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
Beschrijving

ResponsiblePersonFaxNumber

Datatype

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
Beschrijving

ResponsiblePersonE-mailAddressText

Datatype

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
Beschrijving

Patient Demographics / Pre-treatment Characteristics

Alias
UMLS CUI-1
C1704791
Patient Initials
Beschrijving

Patient Initials

Datatype

text

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

Gender

Datatype

text

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

PersonBirthDate

Datatype

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
Beschrijving

PersonAddressPostalCode

Datatype

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
Beschrijving

PersonAddressCountryName

Datatype

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)
Beschrijving

PatientPaymentType

Datatype

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
Beschrijving

Racial Group

Datatype

text

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

Ethnic Group

Datatype

text

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

Intensity modulated radiation therapy

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

IMRT usage

Datatype

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?
Beschrijving

IMRT Certification

Datatype

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
Beschrijving

Neurocognitive Testing Certification

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

Person certified for neurocognitive testing

Datatype

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
Beschrijving

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.
Beschrijving

PathologySpecimenCentralReviewerSubmissionInd-2

Datatype

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
Beschrijving

TherapyBeginRequirementInd-2

Datatype

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
Beschrijving

Pre-registration Check

Consent form signed and dated
Beschrijving

InformedConsentFormSignedInd-2

Datatype

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
Beschrijving

InformedConsentFormSignedDate

Datatype

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)
Beschrijving

PatientHealthRecordIndicator

Datatype

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)
Beschrijving

HealthInsurancePortabilityandAccountabilityActTissueDonorAuthorizationDate

Datatype

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
Beschrijving

CentralPathologyReviewPriorRandomizationRequirementInd-2

Datatype

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
Beschrijving

Radiation oncologist confirmed patient eligibility

Datatype

boolean

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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)
CL.1
Code List
Gender
CL Item
Male (MALE)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
CL Item
Female (FEMALE)
C46110 (NCI Thesaurus)
C0086287 (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)
CL.2
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)
CL.3
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)
CL.4
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)
CL.11
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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