ID

2033

Beschreibung

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

Link

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

Stichworte

Versionen (2)
  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

19. September 2012

DOI

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Leukemia NCT00897767 Eligibility - E3903 Registration Worksheet (step 1) - 2952105v1.0

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: E3903 Registration Worksheet (step 1)
    1. No Instruction available.
Eligibility
Beschreibung

Eligibility

Enter the suspected clinical diagnoses
Beschreibung

PersonSuspectedClinicalDiagnosisClinicalTrialEligibilityCriteriaText

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C71458
UMLS 2011AA Property
C0750491
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property
C15607
UMLS 2011AA Property
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.)
Beschreibung

PersonClinicalTrialIdentifierParticipationNumber

Datentyp

text

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

PersonClinicalStudyRegistrationOrTreatmentBeginClinicalTrialEligibilityCriteriaIndicator

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property
C37998
UMLS 2011AA Property
C1518602
NCI Thesaurus Property
C15368
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property
C15206
UMLS 2011AA Property
C0008972
NCI Thesaurus Property
C16112
UMLS 2011AA Property
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'.
Beschreibung

PersonClinicalStudyTreatmentBeginIdentifierClinicalTrialEligibilityCriteriaText

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C15368
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property
C15206
UMLS 2011AA Property
C0008972
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Has written informed consent been obtained
Beschreibung

PatientSignatureConsentInd-2

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
Date Informed Consent Signed
Beschreibung

InformedConsentFormSignedDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Has HIPAA authorization been obtained
Beschreibung

HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator

Datentyp

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
Beschreibung

PatientSignedDischargeMedicalRecordDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25679
NCI Metathesaurus Property
C0012621
NCI Thesaurus Property
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.
Beschreibung

PersonSpecimenMalignantNeoplasmResearchConsentInd-2

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property
C25460
UMLS 2011AA Property
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).
Beschreibung

PatientOtherDiseaseorDisorderClinicalStudyConsentIndicator

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C15206
UMLS 2011AA Property
C0008972
NCI Thesaurus Property
C25460
UMLS 2011AA Property
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.
Beschreibung

PatientAdditionalResearchConsentInd-2

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C25406
UMLS 2011AA Property
C1524062
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
I agree research specimens may be collected with a swab.
Beschreibung

PersonSwabCollectionConsentIndicator

Datentyp

text

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
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property
C17627
UMLS 2011AA Property
C1261188
I agree to provide additional blood for research.
Beschreibung

PersonBloodTissueDonorConsentIndicator

Datentyp

text

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
C12434
UMLS 2011AA Property
C0229664
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
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Ähnliche Modelle

No Instruction available.

1 Formulare
  1. StudyEvent: E3903 Registration Worksheet (step 1)
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
C1516637 (UMLS 2011AA Property)
C15607 (NCI Thesaurus Property)
C0332140 (UMLS 2011AA Property)
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)
C0600091 (UMLS 2011AA Property)
C71104 (NCI Thesaurus Property)
C0008976 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C15206 (NCI Thesaurus ValueDomain)
C0008972 (UMLS 2011AA ValueDomain)
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)
C1518602 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
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)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Item
Has written informed consent been obtained
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
CL.2
Code List
Has written informed consent been obtained
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
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)
C0025102 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
My specimens may be kept for use in research to learn about, prevent, treat, or cure cancer.
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.4
Code List
My specimens may be kept for use in research to learn about, prevent, treat, or cure cancer.
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
My specimens may be kept for use in research about other health problems (for example: diabetes, Alzheimer's disease, or heart disease).
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.5
Code List
My specimens may be kept for use in research about other health problems (for example: diabetes, Alzheimer's disease, or heart disease).
CL Item
No: C49487 (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes: C49488 (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Someone from this institution may contact me in the future to ask me to take part in more research.
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25406 (NCI Thesaurus Property)
C1524062 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.6
Code List
Someone from this institution may contact me in the future to ask me to take part in more research.
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
I agree research specimens may be collected with a swab.
text
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)
C1511481 (UMLS 2011AA Property)
C17627 (NCI Thesaurus Property)
C1261188 (UMLS 2011AA Property)
CL.7
Code List
I agree research specimens may be collected with a swab.
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
I agree to provide additional blood for research.
text
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)
C0229664 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
CL.8
Code List
I agree to provide additional blood for research.
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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