ID

9007

Description

E1608 Registration Worksheet (step 1) Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=876C3FE1-1D5C-9E03-E040-BB89AD434EEA

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=876C3FE1-1D5C-9E03-E040-BB89AD434EEA

Mots-clés

Versions (3)
  1. 19/09/2012 19/09/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 09/01/2015 09/01/2015 - Martin Dugas
Téléchargé le

9 janvier 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy
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Melanoma (Skin) NCT01134614 Eligibility - E1608 Registration Worksheet (step 1) - 3099018v1.0

Anglais

No Instruction available.

1 Formulaires  
  1. StudyEvent: E1608 Registration Worksheet (step 1)
    1. No Instruction available.
Eligibility
Description

Eligibility

Has the eligibility checklist been completed?
Description

EligibilityDeterminationChecklistCompleteEligibilityInd-2

Type de données

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?
Description

Eligibility for trial

Type de données

boolean

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

Consent signed

Type de données

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
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
Has HIPAA authorization been obtained?
Description

HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator

Type de données

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
Description

PatientSignedDischargeMedicalRecordDate

Type de données

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
AJCC Stage
Description

PatientMelanomaAmericanJointCommitteeonCancerStagingEligibilityDeterminationType

Type de données

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3224
UMLS 2011AA Property
C0025202
NCI Thesaurus Property-2
C15608
UMLS 2011AA Property-2
C0332305
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus Property-4
C39315
UMLS 2011AA Property-4
C1515946
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Prior therapy
Description

PriorTherapyAdministeredStatus

Type de données

text

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
I agree to provide additional blood for research.
Description

PersonBloodTissueDonorConsentIndicator

Type de données

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.
Description

PersonTissueSpecimenSubmissionConsentIndicator

Type de données

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

PersonSpecimenMalignantNeoplasmResearchConsentInd-2

Type de données

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 research about other health problems (for example: causes of diabetes, Alzheimer's disease, and heart disease).
Description

SouthwestOncologyGroupPatientTissueSpecimenConsentInd-2

Type de données

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 this institution may contact me in the future to ask me to take part in more research.
Description

PatientAdditionalResearchConsentInd-2

Type de données

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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Similar models

No Instruction available.

1 Formulaires
  1. StudyEvent: E1608 Registration Worksheet (step 1)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
AJCC Stage
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3224 (NCI Thesaurus Property)
C0025202 (UMLS 2011AA Property)
C15608 (NCI Thesaurus Property-2)
C0332305 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C39315 (NCI Thesaurus Property-4)
C1515946 (UMLS 2011AA Property-4)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.5
Code List
AJCC Stage
CL Item
Unresectable (Unresectable)
C14151 (NCI Thesaurus)
C1519810 (UMLS 2011AA)
CL Item
M1a/1b (M1a/1b)
CL Item
M1c (M1c)
Item
Prior therapy
text
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.6
Code List
Prior therapy
CL Item
None (None)
CL Item
Ifn (IFN)
CL Item
One Investigational Therapy Or One Systemic Therapeutic Regimen (One investigational therapy or one systemic therapeutic regimen)
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
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)
SouthwestOncologyGroupPatientTissueSpecimenConsentInd-2
Item
My specimens may be kept for research about other health problems (for example: causes of diabetes, Alzheimer's disease, and heart disease).
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 this institution 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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