ID

8987

Description

E3903 Registration Worksheet (step 1) Collecting Tissue Samples From Patients With Leukemia or Other Blood Disorders Planning to Enroll in an ECOG Leukemia Treatment Clinical Trial Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7586FA81-F57E-351C-E040-BB89AD43544C

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7586FA81-F57E-351C-E040-BB89AD43544C

Mots-clés

Versions (2)
  1. 19/09/2012 19/09/2012 -
  2. 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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Leukemia NCT00897767 Eligibility - E3903 Registration Worksheet (step 1) - 2952105v1.0

Anglais

No Instruction available.

1 Formulaires  
  1. StudyEvent: E3903 Registration Worksheet (step 1)
    1. No Instruction available.
Eligibility
Description

Eligibility

Enter the suspected clinical diagnoses
Description

PersonSuspectedClinicalDiagnosisClinicalTrialEligibilityCriteriaText

Type de données

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C71458
UMLS 2011AA Property
C0750491
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
NCI Thesaurus Property-3
C15607
UMLS 2011AA Property-3
C0332140
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Enter the protocol number(s) of the treatment protocol under consideration (Note: Patients may be entered simultaneously on this laboratory protocol and a chosen treatment trial if immediate treatment is medically indicated and a central review is not mandatory to determine eligibility prior to registration to the treatment trial. The requested materials must be submitted prior to the start of therapy. If a central diagnostic review is performed and does not confirm the diagnosis, treatment on the treatment protocol will be discontinued if medically indicated.)
Description

PersonClinicalTrialIdentifierParticipationNumber

Type de données

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property-2
C25364
UMLS 2011AA Property-2
C0600091
NCI Thesaurus Property-3
C71104
UMLS 2011AA Property-3
C0008976
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ValueDomain-2
C15206
UMLS 2011AA ValueDomain-2
C0008972
Has the patient registered to or started treatment on the respective treatment trial
Description

PersonClinicalStudyRegistrationOrTreatmentBeginClinicalTrialEligibilityCriteriaIndicator

Type de données

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C37998
UMLS 2011AA Property-2
C1518602
NCI Thesaurus Property-3
C15368
NCI Thesaurus Property-4
C25431
UMLS 2011AA Property-3
C0439659
NCI Thesaurus Property-5
C15206
UMLS 2011AA Property-4
C0008972
NCI Thesaurus Property-6
C16112
UMLS 2011AA Property-5
C1516637
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
If the patient is registered to a treatment trial, enter the treatment protocol number(s) followed by the ECOG patient ID on the treatment protocol(s). Others enter 'N/A'.
Description

PersonClinicalStudyTreatmentBeginIdentifierClinicalTrialEligibilityCriteriaText

Type de données

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C15368
NCI Thesaurus Property-3
C25431
UMLS 2011AA Property-2
C0439659
NCI Thesaurus Property-4
C15206
UMLS 2011AA Property-3
C0008972
NCI Thesaurus Property-5
C16112
UMLS 2011AA Property-4
C1516637
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
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
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 use in research about other health problems (for example: diabetes, Alzheimer's disease, or heart disease).
Description

PatientOtherDiseaseorDisorderClinicalStudyConsentIndicator

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-3
C0008972
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-4
C1511481
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
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
I agree research specimens may be collected with a swab.
Description

PersonSwabCollectionConsentIndicator

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus Property-2
C25460
UMLS 2011AA Property-2
C1511481
NCI Thesaurus Property-3
C17627
UMLS 2011AA Property-3
C1261188
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 ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
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
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Similar models

No Instruction available.

1 Formulaires
  1. StudyEvent: E3903 Registration Worksheet (step 1)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Eligibility
PersonSuspectedClinicalDiagnosisClinicalTrialEligibilityCriteriaText
Item
Enter the suspected clinical diagnoses
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C71458 (NCI Thesaurus Property)
C0750491 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C15607 (NCI Thesaurus Property-3)
C0332140 (UMLS 2011AA Property-3)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
PersonClinicalTrialIdentifierParticipationNumber
Item
Enter the protocol number(s) of the treatment protocol under consideration (Note: Patients may be entered simultaneously on this laboratory protocol and a chosen treatment trial if immediate treatment is medically indicated and a central review is not mandatory to determine eligibility prior to registration to the treatment trial. The requested materials must be submitted prior to the start of therapy. If a central diagnostic review is performed and does not confirm the diagnosis, treatment on the treatment protocol will be discontinued if medically indicated.)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property-2)
C0600091 (UMLS 2011AA Property-2)
C71104 (NCI Thesaurus Property-3)
C0008976 (UMLS 2011AA Property-3)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C15206 (NCI Thesaurus ValueDomain-2)
C0008972 (UMLS 2011AA ValueDomain-2)
Item
Has the patient registered to or started treatment on the respective treatment trial
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C37998 (NCI Thesaurus Property-2)
C1518602 (UMLS 2011AA Property-2)
C15368 (NCI Thesaurus Property-3)
C25431 (NCI Thesaurus Property-4)
C0439659 (UMLS 2011AA Property-3)
C15206 (NCI Thesaurus Property-5)
C0008972 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-6)
C1516637 (UMLS 2011AA Property-5)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.1
Code List
Has the patient registered to or started treatment on the respective treatment trial
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Registered Only (Registered only)
CL Item
Started Treatment (Started treatment)
PersonClinicalStudyTreatmentBeginIdentifierClinicalTrialEligibilityCriteriaText
Item
If the patient is registered to a treatment trial, enter the treatment protocol number(s) followed by the ECOG patient ID on the treatment protocol(s). Others enter 'N/A'.
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property-2)
C25431 (NCI Thesaurus Property-3)
C0439659 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-4)
C0008972 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-4)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
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.3
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)
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)
PatientOtherDiseaseorDisorderClinicalStudyConsentIndicator
Item
My specimens may be kept for use in research about other health problems (for example: diabetes, Alzheimer's disease, or heart disease).
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (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)
PersonSwabCollectionConsentIndicator
Item
I agree research specimens may be collected with a swab.
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
C17627 (NCI Thesaurus Property-3)
C1261188 (UMLS 2011AA Property-3)
PersonBloodTissueDonorConsentIndicator
Item
I agree to provide additional blood for research.
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
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)
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