ID

8985

Beskrivning

CALGB-10403 OPEN Registration Worksheet Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=83D35A37-D0A0-FE1A-E040-BB89AD435D90

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=83D35A37-D0A0-FE1A-E040-BB89AD435D90

Nyckelord

Versioner (2)
  1. 2012-09-19 2012-09-19 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
Uppladdad den

9 januari 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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Leukemia NCT00558519 Registration - CALGB-10403 OPEN Registration Worksheet - 3057212v1.0

Engelsk

A Intergroup Phase II Clinical Trial for Adolescents and Young Adults with Untreated Acute Lymphoblastic Leukemia (ALL)

1 Formulär  
Protocol Administration
Beskrivning

Protocol Administration

Date Informed Consent Signed (MM DD YYYY)
Beskrivning

InformedConsentFormSignedDate

Datatyp

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
HIPAA Authorization Date (MM DD YYYY)
Beskrivning

PatientSignedDischargeMedicalRecordDate

Datatyp

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25679
NCI Metathesaurus Property
C0012621
NCI Thesaurus Property-2
C45258
UMLS 2011AA Property
C0025102
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Projected Start Date of Treatment (MM DD YYYY)
Beskrivning

Treatment Begin Date

Datatyp

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
Institution/Affiliate
Beskrivning

Institution Name

Datatyp

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
Physician of Record
Beskrivning

PhysicianPerformingImagingSeriesName

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25674
UMLS 2011AA ObjectClass
C0205549
NCI Thesaurus ObjectClass-2
C18843
UMLS 2011AA ObjectClass-2
C1704382
NCI Thesaurus Property
C25741
UMLS 2011AA Property
C0031831
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Investigator Number
Beskrivning

NationalCancerInstitutePrincipalInvestigatorIdentifierNumber

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C19202
UMLS 2011AA ObjectClass
C1513882
NCI Thesaurus ObjectClass-2
C19924
UMLS 2011AA ObjectClass-2
C1521895
NCI Institution Number
Beskrivning

NCIInstitutionIdentifierCode

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass-2
C19202
UMLS 2011AA ObjectClass-2
C1513882
Patient Demographics/pre-treatment Characteristics2
Beskrivning

Patient Demographics/pre-treatment Characteristics2

Disease (ALL)
Beskrivning

DiseaseDescriptionText

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Certification Of Eligibility
Beskrivning

Certification Of Eligibility

In the opinion of the investigator, is the patient eligible
Beskrivning

Eligibility for trial

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1302261
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25171
Certification Of Eligibility And Protocol Design
Beskrivning

Certification Of Eligibility And Protocol Design

Assigned Treatment Arm
Beskrivning

Protocol Treatment Arm

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C42651
UMLS CUI-1
C1522541
NCI Thesaurus Property
C32141
NCI Thesaurus Property-2
C25426
NCI Thesaurus ValueDomain
C25284
Initial Patient Consent For Specimen Use
Beskrivning

Initial Patient Consent For Specimen Use

Did the patient consent to participate in Study # 9665 (Study # 9665 CALGB Leukemia Tissue Bank If yes, register the patient to Study # 9665 during registration to Study # 10403)
Beskrivning

PatientAncillaryStudyOneEligibilityDeterminationInd-3

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C66832
UMLS 2011AA Property
C0205447
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C16041
UMLS 2011AA Property-3
C1515980
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Did the patient consent to participate in Study # 9862 (Study # 9862 Molecular Genetic Features of Acute Lymphoblastic Leukemia If yes, register the patient to Study # 9862 during registration to Study # 10403)
Beskrivning

PatientAncillaryStudyTwoEligibilityDeterminationInd-3

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C66833
UMLS 2011AA Property
C0205448
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C16041
UMLS 2011AA Property-3
C1515980
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Did the patient agree to complete the Patient Survey (Questionnaire)
Beskrivning

PatientQuestionnaireCompleteInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property-2
C17048
UMLS 2011AA Property-2
C0034394
Initial Patient Consent For Specimen Use
Beskrivning

Initial Patient Consent For Specimen Use

Did the patient consent to participate in Study # S-9007 (Study # S-9007 Marrow and blood samples Mandatory for SWOG institutions If yes, register the patient to Study # S-9007 during registration to Study #10403)
Beskrivning

PatientAncillaryStudyThreeEligibilityDeterminationInd-3

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property-2
C16041
UMLS 2011AA Property-2
C1515980
NCI Thesaurus Property-3
C66834
UMLS 2011AA Property-3
C0205449
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Did the patient consent to participate in Study # S-9910 (Study # S-9910 Marrow aspirate, blood and buccal smear Strongly encouraged for SWOG institutions If yes, register the patient to Study # S-9910 during registration to Study #10403)
Beskrivning

ParticipatingPatientAncillaryStudyConsentInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25608
UMLS 2011AA ObjectClass-2
C0679823
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Metathesaurus Property
CL004903
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Notes:
Beskrivning

Notes:

CRA Name
Beskrivning

ClinicalResearchAssociateResponsiblePersonName

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass-2
C25465
UMLS 2011AA ObjectClass-2
C1516627
CRA Phone
Beskrivning

ClinicalResearchAssociatePersonTelephoneNumber

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25395
UMLS 2011AA Property
C0039457
NCI Thesaurus ObjectClass-2
C25465
UMLS 2011AA ObjectClass-2
C1516627
CRA email
Beskrivning

ClinicalResearchAssociatePersonEmailAddressText

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C25465
UMLS 2011AA ObjectClass-2
C1516627
NCI Thesaurus Property
C42775
UMLS 2011AA Property
C1705961
Lead Institution (Treating if CTSU)
Beskrivning

LeadInstitutionName

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus ObjectClass-2
C25552
UMLS 2011AA ObjectClass-2
C1522538
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain-2
C21541
UMLS 2011AA ValueDomain-2
C0018704
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Similar models

A Intergroup Phase II Clinical Trial for Adolescents and Young Adults with Untreated Acute Lymphoblastic Leukemia (ALL)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Protocol Administration
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)
PatientSignedDischargeMedicalRecordDate
Item
HIPAA Authorization Date (MM DD YYYY)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0012621 (NCI Metathesaurus Property)
C45258 (NCI Thesaurus Property-2)
C0025102 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
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)
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)
PhysicianPerformingImagingSeriesName
Item
Physician of Record
text
C25674 (NCI Thesaurus ObjectClass)
C0205549 (UMLS 2011AA ObjectClass)
C18843 (NCI Thesaurus ObjectClass-2)
C1704382 (UMLS 2011AA ObjectClass-2)
C25741 (NCI Thesaurus Property)
C0031831 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
NationalCancerInstitutePrincipalInvestigatorIdentifierNumber
Item
NCI Investigator Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19202 (NCI Thesaurus ObjectClass)
C1513882 (UMLS 2011AA ObjectClass)
C19924 (NCI Thesaurus ObjectClass-2)
C1521895 (UMLS 2011AA ObjectClass-2)
NCIInstitutionIdentifierCode
Item
NCI Institution Number
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19202 (NCI Thesaurus ObjectClass-2)
C1513882 (UMLS 2011AA ObjectClass-2)
Item Group
Patient Demographics/pre-treatment Characteristics2
DiseaseDescriptionText
Item
Disease (ALL)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item Group
Certification Of Eligibility
Eligibility for trial
Item
In the opinion of the investigator, is the patient eligible
boolean
C38148 (NCI Thesaurus ValueDomain)
C1302261 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property)
Item Group
Certification Of Eligibility And Protocol Design
Item
Assigned Treatment Arm
text
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C1522541 (UMLS CUI-1)
C32141 (NCI Thesaurus Property)
C25426 (NCI Thesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)
CL.2
Code List
Assigned Treatment Arm
CL Item
Sequential Chemotherapy (Sequential Chemotherapy)
Item Group
Initial Patient Consent For Specimen Use
PatientAncillaryStudyOneEligibilityDeterminationInd-3
Item
Did the patient consent to participate in Study # 9665 (Study # 9665 CALGB Leukemia Tissue Bank If yes, register the patient to Study # 9665 during registration to Study # 10403)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C66832 (NCI Thesaurus Property)
C0205447 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C16041 (NCI Thesaurus Property-3)
C1515980 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientAncillaryStudyTwoEligibilityDeterminationInd-3
Item
Did the patient consent to participate in Study # 9862 (Study # 9862 Molecular Genetic Features of Acute Lymphoblastic Leukemia If yes, register the patient to Study # 9862 during registration to Study # 10403)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C66833 (NCI Thesaurus Property)
C0205448 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C16041 (NCI Thesaurus Property-3)
C1515980 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientQuestionnaireCompleteInd-2
Item
Did the patient agree to complete the Patient Survey (Questionnaire)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C17048 (NCI Thesaurus Property-2)
C0034394 (UMLS 2011AA Property-2)
Item Group
Initial Patient Consent For Specimen Use
PatientAncillaryStudyThreeEligibilityDeterminationInd-3
Item
Did the patient consent to participate in Study # S-9007 (Study # S-9007 Marrow and blood samples Mandatory for SWOG institutions If yes, register the patient to Study # S-9007 during registration to Study #10403)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C16041 (NCI Thesaurus Property-2)
C1515980 (UMLS 2011AA Property-2)
C66834 (NCI Thesaurus Property-3)
C0205449 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
ParticipatingPatientAncillaryStudyConsentInd-2
Item
Did the patient consent to participate in Study # S-9910 (Study # S-9910 Marrow aspirate, blood and buccal smear Strongly encouraged for SWOG institutions If yes, register the patient to Study # S-9910 during registration to Study #10403)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus ObjectClass-2)
C0679823 (UMLS 2011AA ObjectClass-2)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
CL004903 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Notes:
ClinicalResearchAssociateResponsiblePersonName
Item
CRA Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25465 (NCI Thesaurus ObjectClass-2)
C1516627 (UMLS 2011AA ObjectClass-2)
ClinicalResearchAssociatePersonTelephoneNumber
Item
CRA Phone
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA Property)
C25465 (NCI Thesaurus ObjectClass-2)
C1516627 (UMLS 2011AA ObjectClass-2)
ClinicalResearchAssociatePersonEmailAddressText
Item
CRA email
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25465 (NCI Thesaurus ObjectClass-2)
C1516627 (UMLS 2011AA ObjectClass-2)
C42775 (NCI Thesaurus Property)
C1705961 (UMLS 2011AA Property)
LeadInstitutionName
Item
Lead Institution (Treating if CTSU)
text
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25552 (NCI Thesaurus ObjectClass-2)
C1522538 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
C0018704 (UMLS 2011AA ValueDomain-2)
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