ID

11188

Beschreibung

ACNS0122 Eligibility Worksheet NCT00047320 Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BD908887-2F0D-1578-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BD908887-2F0D-1578-E034-0003BA12F5E7

Stichworte

Versionen (3)
  1. 26.08.12 26.08.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 21.06.15 21.06.15 -
Hochgeladen am

21. Juni 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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ACNS0122 Eligibility Worksheet NCT00047320

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: ACNS0122 Eligibility Worksheet
    1. No Instruction available.
Header
Beschreibung

Header

Name
Beschreibung

Institution Name

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Study Number
Beschreibung

Protocol ID COG

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516477
NCI Thesaurus Property
C25364
Study Number
Beschreibung

Protocol ID COG

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516477
NCI Thesaurus Property
C25364
COG Number
Beschreibung

PatientCOGIdentifierNumber

Datentyp

text

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
C39353
UMLS 2011AA Property-2
C1516477
Patient Name
Beschreibung

Patient Name

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1299487
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
Today's date
Beschreibung

Form Completion Date

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS CUI-1
C1549507
NCI Thesaurus Property
C25250
NCI Thesaurus Property-2
C25604
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Date worksheet entered into RDE
Beschreibung

DataEnteredDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C37949
UMLS 2011AA Property
C1521975
Eligibility Assessment
Beschreibung

Eligibility Assessment

Was the patient greater than 3 years of age and less than 25 years of age at diagnosis?
Beschreibung

PatientRequiredAgeInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25652
UMLS 2011AA Property
C1514873
NCI Thesaurus Property-2
C25150
UMLS 2011AA Property-2
C0001779
Did the patient have histologic verification of one of the following? -Endodermal sinus tumor (yolk sac tumor); -Embryonal carcinoma; -Choriocarcinoma; -Immature teratoma; -Teratoma with malignant transformation; -Mixed germ cell tumor
Beschreibung

DiseaseHistologicDiagnosisInd

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Did the patient have any histologically confirmed germ cell tumor with elevation of serum/CSF beta HCG >50 IU/dl or any elevation of CSF alpha fetoprotein >10IU/L
Beschreibung

GermCellTumorEligibilityInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Did the patient have histologically unconfirmed pineal and/or suprasellar tumors with serum/CSF tumor markers of beta>50 IU/dl or any elevation of alpha fetoprotein >10 IU/L?
Beschreibung

BrainTumorEligibilityInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Was surgery performed?
Beschreibung

PriorSurgeryPerformedInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
was a cranial MRI with gadolinium obtained prior to induction or pre-operative and post-operative? (If yes,)
Beschreibung

CranialMRIPerformedInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
No
Beschreibung

SpinalMRIPerformedInd-2

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
No
Beschreibung

SpinalMRIPerformedInd-2

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
No
Beschreibung

SpinalMRIPerformedInd-2

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Will the start of treatment begin within 31 days of initial diagnosis and within 7 days from study enrollment?
Beschreibung

TreatmentRequiredBeginDateInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Karnofsky Performance Score
Beschreibung

KarnofskyPerformanceStatusScale

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C28013
UMLS 2011AA ObjectClass
C0206065
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Lansky Play Score
Beschreibung

LanskyPerformanceStatusScale

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C25361
UMLS 2011AA ObjectClass
C0597198
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Does the patient have a life expectancy of more than or equal to 2 months?
Beschreibung

PatientLifeExpectancyEligibilityDeterminationInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C37987
UMLS 2011AA Property
C0376558
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C25359
UMLS 2011AA Property-3
C0679138
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have a life expectancy of more than or equal to 2 months?
Beschreibung

PatientLifeExpectancyEligibilityDeterminationInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C37987
UMLS 2011AA Property
C0376558
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C25359
UMLS 2011AA Property-3
C0679138
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has patient received prior treatment other than surgery and corticosteriods?
Beschreibung

CancerPriorTreatmentInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C15368
Did patient receive growth hormone therapy?
Beschreibung

PriorGrowthHormoneTherapyInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C15368
Does the patient have adequate bone marrow function?
Beschreibung

PatientBoneMarrowFunctionRequiredInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25518
UMLS 2011AA Property
C0542341
Does the patient have adequate renal function?
Beschreibung

PatientRenalFunctionRequiredInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25518
UMLS 2011AA Property
C0542341
Does the patient have adequate Central Nervous System function?
Beschreibung

PatientCNSFunctionRequiredInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25518
UMLS 2011AA Property
C0542341
is the patient pregnant and/or breastfeeding? (If female,)
Beschreibung

PatientPregnancyInd

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25742
UMLS 2011AA Property
C0032961
Has the patient and/or their parents or legal guardians signed a written informed consent?
Beschreibung

InformedConsentFormSignedDate

Datentyp

boolean

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
Have all institutional, FDA, and NCI requirements for human studies been met?
Beschreibung

StudyCompleteRequirementsInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15206
UMLS 2011AA ObjectClass
C0008972
NCI Thesaurus Property
C38015
Ccrr Module For Acns0122 Eligibility Worksheet
Beschreibung

Ccrr Module For Acns0122 Eligibility Worksheet

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1 Formulare
  1. StudyEvent: ACNS0122 Eligibility Worksheet
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header
Institution Name
Item
Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Protocol ID COG
Item
Study Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516477 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Protocol ID COG
Item
Study Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516477 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
PatientCOGIdentifierNumber
Item
COG Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C39353 (NCI Thesaurus Property-2)
C1516477 (UMLS 2011AA Property-2)
Patient Name
Item
Patient Name
text
C25191 (NCI Thesaurus ValueDomain)
C1299487 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Form Completion Date
Item
Today's date
date
C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
DataEnteredDate
Item
Date worksheet entered into RDE
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C37949 (NCI Thesaurus Property)
C1521975 (UMLS 2011AA Property)
Item Group
Eligibility Assessment
PatientRequiredAgeInd-2
Item
Was the patient greater than 3 years of age and less than 25 years of age at diagnosis?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25652 (NCI Thesaurus Property)
C1514873 (UMLS 2011AA Property)
C25150 (NCI Thesaurus Property-2)
C0001779 (UMLS 2011AA Property-2)
DiseaseHistologicDiagnosisInd
Item
Did the patient have histologic verification of one of the following? -Endodermal sinus tumor (yolk sac tumor); -Embryonal carcinoma; -Choriocarcinoma; -Immature teratoma; -Teratoma with malignant transformation; -Mixed germ cell tumor
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
GermCellTumorEligibilityInd-2
Item
Did the patient have any histologically confirmed germ cell tumor with elevation of serum/CSF beta HCG >50 IU/dl or any elevation of CSF alpha fetoprotein >10IU/L
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
BrainTumorEligibilityInd-2
Item
Did the patient have histologically unconfirmed pineal and/or suprasellar tumors with serum/CSF tumor markers of beta>50 IU/dl or any elevation of alpha fetoprotein >10 IU/L?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
PriorSurgeryPerformedInd-3
Item
Was surgery performed?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
CranialMRIPerformedInd-2
Item
was a cranial MRI with gadolinium obtained prior to induction or pre-operative and post-operative? (If yes,)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
SpinalMRIPerformedInd-2
Item
No
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
SpinalMRIPerformedInd-2
Item
No
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
SpinalMRIPerformedInd-2
Item
No
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
TreatmentRequiredBeginDateInd-2
Item
Will the start of treatment begin within 31 days of initial diagnosis and within 7 days from study enrollment?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item
Karnofsky Performance Score
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C28013 (NCI Thesaurus ObjectClass)
C0206065 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.9
Code List
Karnofsky Performance Score
CL Item
100 (Normal, no complaints, no evidence of disease.)
CL Item
90 (Able to carry on normal activity, minor signs or symptoms of disease.)
CL Item
80 (Normal activity with effort, some signs or symptoms of disease.)
CL Item
70 (Cares for self. Unable to carry on normal activity or to do active work.)
CL Item
60 (Requires occasional assistance, but is able to care for most of own needs.)
CL Item
50 (Requires considerable assistance and frequent medical care.)
CL Item
40 (Disabled, requires special care and assistance.)
CL Item
30 (Severely disabled, hospitalization is indicated although death is not imminent.)
CL Item
20 (Hospitalization necessary, very sick, active supportive treatment necessary,)
CL Item
10 (Moribund, fatal processes progressing rapidly.)
CL Item
0 (Dead.)
C0919414 (NCI Metathesaurus)
Item
Lansky Play Score
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25361 (NCI Thesaurus ObjectClass)
C0597198 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.10
Code List
Lansky Play Score
CL Item
100 (Fully active, normal)
CL Item
90 (Minor restrictions in physically strenuous activity.)
CL Item
80 (Active, but tires more quickly.)
CL Item
70 (Both greater restriction of and less time spent in play activity.)
CL Item
60 (Up and around, but minimal active play; keeps busy with quieter activities.)
CL Item
50 (Gets dressed but lies around much of the day, no active play, able to participate in all quiet play and activities.)
CL Item
40 (Mostly in bed; participates in quiet activities.)
CL Item
30 (In bed; needs assistance even for quiet play.)
CL Item
20 (Often sleeping; play entirely limited to very passive activities.)
CL Item
10 (No play; does not get out of bed.)
CL Item
0 (Unresponsive.)
C0919414 (NCI Metathesaurus)
PatientLifeExpectancyEligibilityDeterminationInd-2
Item
Does the patient have a life expectancy of more than or equal to 2 months?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C37987 (NCI Thesaurus Property)
C0376558 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25359 (NCI Thesaurus Property-3)
C0679138 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientLifeExpectancyEligibilityDeterminationInd-2
Item
Does the patient have a life expectancy of more than or equal to 2 months?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C37987 (NCI Thesaurus Property)
C0376558 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25359 (NCI Thesaurus Property-3)
C0679138 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CancerPriorTreatmentInd-3
Item
Has patient received prior treatment other than surgery and corticosteriods?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property-2)
PriorGrowthHormoneTherapyInd-2
Item
Did patient receive growth hormone therapy?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus Property)
PatientBoneMarrowFunctionRequiredInd-2
Item
Does the patient have adequate bone marrow function?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
PatientRenalFunctionRequiredInd-2
Item
Does the patient have adequate renal function?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
PatientCNSFunctionRequiredInd-2
Item
Does the patient have adequate Central Nervous System function?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
Item
is the patient pregnant and/or breastfeeding? (If female,)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
CL.17
Code List
is the patient pregnant and/or breastfeeding? (If female,)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
CL Item
No, And Not Nursing (no, and not nursing)
CL Item
No, But Nursing (no, but nursing)
InformedConsentFormSignedDate
Item
Has the patient and/or their parents or legal guardians signed a written informed consent?
boolean
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)
StudyCompleteRequirementsInd-2
Item
Have all institutional, FDA, and NCI requirements for human studies been met?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C38015 (NCI Thesaurus Property)
Item Group
Ccrr Module For Acns0122 Eligibility Worksheet
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