ID

10218

Beschrijving

SWOG S1108 REGISTRATION WORKSHEET Alisertib in Treating Patients With Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma NCT01466881 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AA4F8583-EC8E-07C8-E040-BB89AD430929

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AA4F8583-EC8E-07C8-E040-BB89AD430929

Trefwoorden

Versies (2)
  1. 15-05-15 15-05-15 - Martin Dugas
  2. 15-03-21 15-03-21 - Dr. rer. medic Philipp Neuhaus
Geüploaded op

15 mei 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Lymphoma REGISTRATION SWOG S1108 NCT01466881

Engels

INSTRUCTIONS: All of the information on this Registration Worksheet and the Protocol Eligibility Section must be answered appropriately for a patient to be considered eligible for registration. This Registration Worksheet must be entirely filled out and referred to during the registration. Do NOT submit this worksheet as part of the patient data

1 Formulieren  
Protocol Information
Beschrijving

Protocol Information

Alias
UMLS CUI-1
C1507394
Trial Activation Date
Beschrijving

ClinicalStudyProtocolAmendmentActivationDate

Datatype

date

Maateenheden
  • MM DD YYYY
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C25320
NCI Thesaurus Property
C64382
NCI Thesaurus Property-2
C41200
UMLS CUI-1
C1515882
MM DD YYYY
Last Amended Date
Beschrijving

DataAmendedLastDate

Datatype

date

Maateenheden
  • MM DD YYYY
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25551
UMLS CUI-1
C0680532
UMLS CUI-2
C0011008
MM DD YYYY
Registration Step
Beschrijving

RegistrationStepNumber

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25646
UMLS 2011AA ObjectClass
C1514821
NCI Thesaurus Property
C16154
UMLS 2011AA Property
C1704379
NCI Thesaurus ValueDomain-2
C16154
UMLS 2011AA ValueDomain-2
C1704379
Swog Patient Id
Beschrijving

Swog Patient Id

SWOG Patient ID Status
Beschrijving

PatientSouthwestOncologyGroupIdentifierStatus

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25699
UMLS 2011AA Property-2
C1519429
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
SWOG Patient ID
Beschrijving

PatientSouthwestOncologyGroupIdentifierNumber

Datatype

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25699
UMLS 2011AA Property-2
C1519429
Registrar's SWOG Roster ID Number
Beschrijving

RegistrarSouthwestOncologyGroupIdentifierNumber

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25699
UMLS 2011AA Property-2
C1519429
NCI Thesaurus ObjectClass
C25357
UMLS 2011AA ObjectClass
C0557514
SWOG Investigator Number
Beschrijving

SouthwestOncologyGroupInvestigatorIdentifierNumber

Datatype

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25699
UMLS 2011AA ObjectClass
C1519429
NCI Thesaurus ObjectClass-2
C17089
UMLS 2011AA ObjectClass-2
C0035173
SWOG Treating Institution Number
Beschrijving

SouthwestOncologyGroupTreatingInstitutionIdentifierNumber

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25699
UMLS 2011AA ObjectClass
C1519429
NCI Thesaurus ObjectClass-2
C25705
UMLS 2011AA ObjectClass-2
C1522326
NCI Thesaurus ObjectClass-3
C41206
UMLS 2011AA ObjectClass-3
C1272753
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Demography
Beschrijving

Demography

Patient First Name
Beschrijving

PatientFirstName

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
Patient Middle Name
Beschrijving

PatientMiddleName

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25569
UMLS 2011AA Property-2
C0444598
Patient Last Name
Beschrijving

PatientLastName

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25551
UMLS 2011AA Property-2
C1517741
Patient Information
Beschrijving

Patient Information

Alias
UMLS CUI-1
C1955348
Date Informed Consent Signed
Beschrijving

InformedConsentFormSignedDate

Datatype

date

Maateenheden
  • MM DD YYYY
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
NCI Thesaurus Property
C25679
UMLS CUI-1
C2985782
MM DD YYYY
Date HIPAA Authorization signed (Not required if Country of Residence is not USA MM DD YYYY)
Beschrijving

ProtocolPrivacyApprovedDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25425
UMLS 2011AA Property
C0205540
Projected Start Date of Treatment
Beschrijving

TreatmentProjectedBeginDate

Datatype

date

Maateenheden
  • MM DD YYYY
Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25631
NCI Thesaurus Property
C25431
NCI Thesaurus Property-2
C25275
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-1
C1531783
MM DD YYYY
Has the SWOG Registration Worksheet been completed entirely and is the patient eligible according to the current version of protocol section 5.0?
Beschrijving

SouthwestOncologyGroupPatientRegistrationEligibilityDeterminationInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ObjectClass-2
C25699
NCI Thesaurus Property
C25646
NCI Thesaurus Property-2
C25171
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C1302261
Indicate how the patient answered the following questions on the consent form
Beschrijving

Indicate how the patient answered the following questions on the consent form

Alias
UMLS CUI-1
C0009797
My specimens may be kept for use in research to learn about, prevent, treat, or cure cancer.
Beschrijving

PersonSpecimenMalignantNeoplasmResearchConsentInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C9305
NCI Thesaurus Property-3
C19157
NCI Thesaurus Property-4
C25460
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0006826
UMLS CUI-2
C0370003
UMLS CUI-3
C1511481
My specimens may be kept for use in research about other health problems (for example: diabetes, Alzheimer's disease, or heart disease).
Beschrijving

PatientOtherDiseaseorDisorderClinicalStudyConsentInd-2

Datatype

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
C38147
UMLS 2011AA ValueDomain
C1512698
Someone may contact me in the future to ask me to allow other uses of my specimens.
Beschrijving

PatientContactConsentInd-3

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C67527
NCI Thesaurus Property-2
C25460
NCI Thesaurus Property-3
C16452
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1522577
UMLS CUI-2
C0521104
I agree to allow my study doctor, or someone approved by my study doctor, to contact me regarding future research involving my participation in this study
Beschrijving

SouthwestOncologyGroupPatientResearchConsentInd-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
C15319
NCI Thesaurus Property-2
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
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Similar models

INSTRUCTIONS: All of the information on this Registration Worksheet and the Protocol Eligibility Section must be answered appropriately for a patient to be considered eligible for registration. This Registration Worksheet must be entirely filled out and referred to during the registration. Do NOT submit this worksheet as part of the patient data

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Protocol Information
C1507394 (UMLS CUI-1)
Clinical Study Activation Date
Item
Trial Activation Date
date
C25164 (NCI Thesaurus ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C64382 (NCI Thesaurus Property)
C41200 (NCI Thesaurus Property-2)
C1515882 (UMLS CUI-1)
Amendment date
Item
Last Amended Date
date
C25164 (NCI Thesaurus ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
C25551 (NCI Thesaurus ValueDomain-2)
C0680532 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
RegistrationStepNumber
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain-2)
C1704379 (UMLS 2011AA ValueDomain-2)
Item Group
Swog Patient Id
Item
SWOG Patient ID Status
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property-2)
C1519429 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.1
Code List
SWOG Patient ID Status
CL Item
New Patient (New patient)
CL Item
Previous Patient (Previous patient)
PatientSouthwestOncologyGroupIdentifierNumber
Item
SWOG Patient ID
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property-2)
C1519429 (UMLS 2011AA Property-2)
RegistrarSouthwestOncologyGroupIdentifierNumber
Item
Registrar's SWOG Roster ID Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property-2)
C1519429 (UMLS 2011AA Property-2)
C25357 (NCI Thesaurus ObjectClass)
C0557514 (UMLS 2011AA ObjectClass)
SouthwestOncologyGroupInvestigatorIdentifierNumber
Item
SWOG Investigator Number
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus ObjectClass)
C1519429 (UMLS 2011AA ObjectClass)
C17089 (NCI Thesaurus ObjectClass-2)
C0035173 (UMLS 2011AA ObjectClass-2)
SouthwestOncologyGroupTreatingInstitutionIdentifierNumber
Item
SWOG Treating Institution Number
float
C25699 (NCI Thesaurus ObjectClass)
C1519429 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
C41206 (NCI Thesaurus ObjectClass-3)
C1272753 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
Item Group
Demography
PatientFirstName
Item
Patient First Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
PatientMiddleName
Item
Patient Middle Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)
PatientLastName
Item
Patient Last Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property-2)
C1517741 (UMLS 2011AA Property-2)
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Informed consent date
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C25679 (NCI Thesaurus Property)
C2985782 (UMLS CUI-1)
ProtocolPrivacyApprovedDate
Item
Date HIPAA Authorization signed (Not required if Country of Residence is not USA MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25425 (NCI Thesaurus Property)
C0205540 (UMLS 2011AA Property)
Date treatment started
Item
Projected Start Date of Treatment
date
C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass-2)
C25431 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C1531783 (UMLS CUI-1)
Patient eligible
Item
Has the SWOG Registration Worksheet been completed entirely and is the patient eligible according to the current version of protocol section 5.0?
boolean
C16960 (NCI Thesaurus ObjectClass)
C25699 (NCI Thesaurus ObjectClass-2)
C25646 (NCI Thesaurus Property)
C25171 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1302261 (UMLS CUI-1)
Item Group
Indicate how the patient answered the following questions on the consent form
C0009797 (UMLS CUI-1)
Research use of specimen permitted
Item
My specimens may be kept for use in research to learn about, prevent, treat, or cure cancer.
boolean
C25190 (NCI Thesaurus ObjectClass)
C15319 (NCI Thesaurus Property)
C9305 (NCI Thesaurus Property-2)
C19157 (NCI Thesaurus Property-3)
C25460 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0006826 (UMLS CUI-1)
C0370003 (UMLS CUI-2)
C1511481 (UMLS CUI-3)
PatientOtherDiseaseorDisorderClinicalStudyConsentInd-2
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)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Permission to contact
Item
Someone may contact me in the future to ask me to allow other uses of my specimens.
boolean
C16960 (NCI Thesaurus ObjectClass)
C67527 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C16452 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1522577 (UMLS CUI-1)
C0521104 (UMLS CUI-2)
SouthwestOncologyGroupPatientResearchConsentInd-2
Item
I agree to allow my study doctor, or someone approved by my study doctor, to contact me regarding future research involving my participation in this study
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25699 (NCI Thesaurus ObjectClass-2)
C1519429 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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