ID

9021

Beschrijving

E1609 Registration Worksheet (step 1) Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III or Stage IV Melanoma That Has Been Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A1C001A9-8344-A8EA-E040-BB89AD4301D2

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A1C001A9-8344-A8EA-E040-BB89AD4301D2

Trefwoorden

Versies (3)
  1. 19-09-12 19-09-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 09-01-15 09-01-15 - Martin Dugas
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9 januari 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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Melanoma (Skin) NCT01274338 Eligibility - E1609 Registration Worksheet (step 1) - 3229501v1.0

Engels

No Instruction available.

1 Formulieren  
  1. StudyEvent: E1609 Registration Worksheet (step 1)
    1. No Instruction available.
Eligibility
Beschrijving

Eligibility

Has the eligibility checklist been completed
Beschrijving

EligibilityDeterminationChecklistCompleteEligibilityInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ObjectClass
C25171
UMLS 2011AA ObjectClass
C0013893
NCI Thesaurus Property-2
C49073
UMLS 2011AA Property-2
C1707357
In the opinion of the investigator, is the patient eligible?
Beschrijving

Eligibility for trial

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1302261
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25171
Has written informed consent been obtained
Beschrijving

Consent signed

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0742766
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25678
NCI Thesaurus Property-2
C25460
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
Has HIPAA authorization been obtained
Beschrijving

HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C62504
UMLS 2011AA ObjectClass
C0600593
NCI Thesaurus Property
C41192
UMLS 2011AA Property
C1524004
HIPAA Authorization Date
Beschrijving

PatientSignedDischargeMedicalRecordDate

Datatype

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
Surgically resected AJCC stage
Beschrijving

SurgicalProcedureMelanomaStageGroupingPerformedMelanomaType

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C3224
UMLS 2011AA Property
C0025202
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus Property-3
C38027
UMLS 2011AA Property-3
C1519504
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Is the registering site a CCOP?
Beschrijving

EnrollmentInstitutionCommunityClinicalOncologyProgramMemberAffiliationInd-3

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C41206
UMLS 2011AA ObjectClass
C1272753
NCI Thesaurus ObjectClass-2
C37948
UMLS 2011AA ObjectClass-2
C1516879
NCI Thesaurus Property
C25412
UMLS 2011AA Property
C1510825
NCI Thesaurus Property-2
C16097
UMLS 2011AA Property-2
C1516732
NCI Thesaurus Property-3
C25368
UMLS 2011AA Property-3
C0680022
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
I agree to provide additional blood for research.
Beschrijving

PersonBloodTissueDonorConsentIndicator

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25168
UMLS 2011AA Property
C0040288
NCI Thesaurus Property-2
C12434
UMLS 2011AA Property-2
C0229664
NCI Thesaurus Property-3
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
I agree my tissue will be submitted for research.
Beschrijving

PersonTissueSpecimenSubmissionConsentIndicator

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C12801
UMLS 2011AA Property
C0040300
NCI Thesaurus Property-2
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-3
C25694
UMLS 2011AA Property-3
C1515022
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-4
C1511481
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
May your coded samples and related coded information be kept for use in research to learn about, prevent, find or treat cancer? This may also include research on inherited traits (genes passed on in families).
Beschrijving

PersonSpecimenMalignantNeoplasmResearchConsentInd-2

Datatype

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
May your coded samples and related coded information be kept for use in research to learn about, prevent, find or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)? This may also include research on inherited traits (genes passed on in families).
Beschrijving

SouthwestOncologyGroupPatientTissueSpecimenConsentInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25699
UMLS 2011AA ObjectClass-2
C1519429
NCI Thesaurus Property
C12801
UMLS 2011AA Property
C0040300
NCI Thesaurus Property-2
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-3
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Someone from my hospital or the Eastern Cooperative Oncology Group may contact me in the future to ask me to take part in more research.
Beschrijving

PatientAdditionalResearchConsentInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25406
UMLS 2011AA Property
C1524062
NCI Thesaurus Property-3
C25460
UMLS 2011AA Property-2
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
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No Instruction available.

1 Formulieren
  1. StudyEvent: E1609 Registration Worksheet (step 1)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Eligibility
EligibilityDeterminationChecklistCompleteEligibilityInd-2
Item
Has the eligibility checklist been completed
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25171 (NCI Thesaurus ObjectClass)
C0013893 (UMLS 2011AA ObjectClass)
C49073 (NCI Thesaurus Property-2)
C1707357 (UMLS 2011AA Property-2)
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)
Consent signed
Item
Has written informed consent been obtained
boolean
C38147 (NCI Thesaurus ValueDomain)
C0742766 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25678 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
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
Has HIPAA authorization been obtained
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
CL.4
Code List
Has HIPAA authorization been obtained
CL Item
No: C49487 (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes: C49488 (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Exempt - Non-usa Participant (Exempt - non-USA participant)
PatientSignedDischargeMedicalRecordDate
Item
HIPAA Authorization Date
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)
Item
Surgically resected AJCC stage
text
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C3224 (NCI Thesaurus Property)
C0025202 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C38027 (NCI Thesaurus Property-3)
C1519504 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.5
Code List
Surgically resected AJCC stage
CL Item
Melanoma Stage Iiib (IIIB)
CL Item
Melanoma Stage Iiic (IIIC)
CL Item
Melanoma M1a (M1a)
CL Item
Melanoma M1b (M1b)
EnrollmentInstitutionCommunityClinicalOncologyProgramMemberAffiliationInd-3
Item
Is the registering site a CCOP?
boolean
C41206 (NCI Thesaurus ObjectClass)
C1272753 (UMLS 2011AA ObjectClass)
C37948 (NCI Thesaurus ObjectClass-2)
C1516879 (UMLS 2011AA ObjectClass-2)
C25412 (NCI Thesaurus Property)
C1510825 (UMLS 2011AA Property)
C16097 (NCI Thesaurus Property-2)
C1516732 (UMLS 2011AA Property-2)
C25368 (NCI Thesaurus Property-3)
C0680022 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PersonBloodTissueDonorConsentIndicator
Item
I agree to provide additional blood for research.
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25168 (NCI Thesaurus Property)
C0040288 (UMLS 2011AA Property)
C12434 (NCI Thesaurus Property-2)
C0229664 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
PersonTissueSpecimenSubmissionConsentIndicator
Item
I agree my tissue will be submitted for research.
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C12801 (NCI Thesaurus Property)
C0040300 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25694 (NCI Thesaurus Property-3)
C1515022 (UMLS 2011AA Property-3)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
PersonSpecimenMalignantNeoplasmResearchConsentInd-2
Item
May your coded samples and related coded information be kept for use in research to learn about, prevent, find or treat cancer? This may also include research on inherited traits (genes passed on in families).
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)
SouthwestOncologyGroupPatientTissueSpecimenConsentInd-2
Item
May your coded samples and related coded information be kept for use in research to learn about, prevent, find or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)? This may also include research on inherited traits (genes passed on in families).
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25699 (NCI Thesaurus ObjectClass-2)
C1519429 (UMLS 2011AA ObjectClass-2)
C12801 (NCI Thesaurus Property)
C0040300 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientAdditionalResearchConsentInd-2
Item
Someone from my hospital or the Eastern Cooperative Oncology Group may contact me in the future to ask me to take part in more research.
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25406 (NCI Thesaurus Property-2)
C1524062 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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