ID

7073

Descrizione

The Division of Cancer Prevention's compliance case report form (CRF) template. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=51ACB3DE-4427-492A-E044-0003BA3F9857

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=51ACB3DE-4427-492A-E044-0003BA3F9857

Keywords

versioni (2)
  1. 27/08/12 27/08/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
Caricato su

9 gennaio 2015

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy
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Compliance - 2765075v1.0

Inglese

No Instruction available.

1 moduli  
  1. StudyEvent: Compliance
    1. No Instruction available.
Screening
Descrizione

Screening

DCP Protocol #
Descrizione

Protocol ID NCI

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1513882
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C19202
Institution Code
Descrizione

NationalCancerInstituteInstituteCode

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participant ID
Descrizione

ParticipantIdentifier

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25364
UMLS 2011AA ValueDomain
C0600091
Visit Type
Descrizione

VisitTypeText

Tipo di dati

text

Alias
NCI Thesaurus Property
C25284
UMLS 2011AA Property
C0332307
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25716
UMLS 2011AA ObjectClass
C0545082
Visit Date
Descrizione

VisitDate

Tipo di dati

date

Alias
NCI Thesaurus Property
C25164
UMLS 2011AA Property
C0011008
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C25716
UMLS 2011AA ObjectClass
C0545082
Compliance
Descrizione

Compliance

First Dose taken this period date
Descrizione

FirstDoseDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25256
UMLS 2011AA Property-2
C1265611
Last Dose taken this period date
Descrizione

LastDosePeriodDate

Tipo di dati

date

Alias
NCI Thesaurus Property
C25164
UMLS 2011AA Property
C0011008
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus ObjectClass-2
C25551
UMLS 2011AA ObjectClass-2
C1517741
Was agent interrupted during this period?
Descrizione

AgentInterruptedIndicator

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Metathesaurus Property
CL212531
If Yes, indicate number of interruptions this period
Descrizione

AdditionalAgentInterruptionsNumberCount

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C25406
UMLS 2011AA ObjectClass-2
C1524062
NCI Thesaurus Property
C25542
UMLS 2011AA Property
C1512900
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
Was agent regimen modified during this period?
Descrizione

AgentDoseModifiedIndicator

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Amount of agent provided at last visit.
Descrizione

AgentProvidedAmount

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus ValueDomain-2
C25417
NCI Thesaurus ValueDomain-3
C64658
UMLS 2011AA ValueDomain-2
C1880359
Not Obtained
Descrizione

NotObtainedIndicator

Tipo di dati

text

Alias
NCI Thesaurus Property
C25180
UMLS 2011AA Property
C1522602
NCI Metathesaurus ObjectClass
CL310460
NCI Metathesaurus ObjectClass-2
CL052458
NCI Metathesaurus ValueDomain
C0021212
Amount of agent returned this visit
Descrizione

AgentReturnedAmount

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25417
NCI Thesaurus ValueDomain
C25417
Amount of agent taken this period
Descrizione

ActualDoseAmount

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus ObjectClass-2
C25274
UMLS 2011AA ObjectClass-2
C0237400
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus ValueDomain-2
C25417
NCI Thesaurus ValueDomain-3
C64658
UMLS 2011AA ValueDomain-2
C1880359
Amount of agent missing/not accounted for this period
Descrizione

AgentMissingAmount

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C54031
UMLS 2011AA Property
C1705492
NCI Thesaurus Property-2
C25417
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus ValueDomain-2
C25417
NCI Thesaurus ValueDomain-3
C64658
UMLS 2011AA ValueDomain-2
C1880359
Is the participant compliant with protocol intervention?
Descrizione

ProtocolComplianceIndicator

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus Property
C25194
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain-2
C25180
UMLS 2011AA ValueDomain-2
C1522602
If No, specify reason for noncompliance
Descrizione

NoncomplaintReasonText

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25638
UMLS 2011AA Property
C0392360
NCI Thesaurus ObjectClass
C25594
UMLS 2011AA ObjectClass
C1518422
NCI Thesaurus ObjectClass-2
C25217
UMLS 2011AA ObjectClass-2
C1516048
Was agent provided at this visit?
Descrizione

AgentProvidedIndicator

Tipo di dati

text

Alias
NCI Thesaurus Property
C25180
UMLS 2011AA Property
C1522602
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Amount of agent provided at this visit
Descrizione

AgentProvidedCurrentVisitAmount

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25417
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus ValueDomain-2
C25417
NCI Thesaurus ValueDomain-3
C64658
UMLS 2011AA ValueDomain-2
C1880359
Dcp Template Footer
Descrizione

Dcp Template Footer

Protocol Title
Descrizione

Protocol Title

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986303
NCI Thesaurus ObjectClass
C25320
NCI Thesaurus Property
C42774
Protocol Version
Descrizione

Protocol Version

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2985700
NCI Thesaurus ObjectClass
C25320
NCI Thesaurus Property
C25364
Protocol Date
Descrizione

Protocol Version Date

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985700
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain-2
C25367
Page #
Descrizione

PageNumber

Tipo di dati

float

Alias
NCI Thesaurus Property
C25337
UMLS 2011AA Property
C0237753
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Metathesaurus ObjectClass
C0439643
Total Page Number
Descrizione

CaseReportFormTotalPageNumber

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C40988
UMLS 2011AA ObjectClass
C1516308
NCI Thesaurus Property
C25337
UMLS 2011AA Property
C0237753
NCI Thesaurus Property-2
C25304
UMLS 2011AA Property-2
C0439810
NCI Thesaurus Property-3
C42783
UMLS 2011AA Property-3
C1704732
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
DCP Template Version
Descrizione

DCPTemplateVersionText

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Metathesaurus ObjectClass
C0728990
NCI Thesaurus Property
C25714
UMLS 2011AA Property
C0333052
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Similar models

No Instruction available.

1 moduli
  1. StudyEvent: Compliance
    1. No Instruction available.
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Screening
Protocol ID NCI
Item
DCP Protocol #
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1513882 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C19202 (NCI Thesaurus Property-2)
NationalCancerInstituteInstituteCode
Item
Institution Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ParticipantIdentifier
Item
Participant ID
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25364 (NCI Thesaurus ValueDomain)
C0600091 (UMLS 2011AA ValueDomain)
VisitTypeText
Item
Visit Type
text
C25284 (NCI Thesaurus Property)
C0332307 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25716 (NCI Thesaurus ObjectClass)
C0545082 (UMLS 2011AA ObjectClass)
VisitDate
Item
Visit Date
date
C25164 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C25716 (NCI Thesaurus ObjectClass)
C0545082 (UMLS 2011AA ObjectClass)
Item Group
Compliance
FirstDoseDate
Item
First Dose taken this period date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property-2)
C1265611 (UMLS 2011AA Property-2)
LastDosePeriodDate
Item
Last Dose taken this period date
date
C25164 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus ObjectClass-2)
C1517741 (UMLS 2011AA ObjectClass-2)
Item
Was agent interrupted during this period?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
CL212531 (NCI Metathesaurus Property)
CL.1
Code List
Was agent interrupted during this period?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (N/A)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
AdditionalAgentInterruptionsNumberCount
Item
If Yes, indicate number of interruptions this period
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25406 (NCI Thesaurus ObjectClass-2)
C1524062 (UMLS 2011AA ObjectClass-2)
C25542 (NCI Thesaurus Property)
C1512900 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
Item
Was agent regimen modified during this period?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
CL.2
Code List
Was agent regimen modified during this period?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (N/A)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
AgentProvidedAmount
Item
Amount of agent provided at last visit.
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C25417 (NCI Thesaurus ValueDomain-2)
C64658 (NCI Thesaurus ValueDomain-3)
C1880359 (UMLS 2011AA ValueDomain-2)
Item
Not Obtained
text
C25180 (NCI Thesaurus Property)
C1522602 (UMLS 2011AA Property)
CL310460 (NCI Metathesaurus ObjectClass)
CL052458 (NCI Metathesaurus ObjectClass-2)
C0021212 (NCI Metathesaurus ValueDomain)
CL.3
Code List
Not Obtained
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
AgentReturnedAmount
Item
Amount of agent returned this visit
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25417 (NCI Thesaurus Property)
C25417 (NCI Thesaurus ValueDomain)
ActualDoseAmount
Item
Amount of agent taken this period
text
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25274 (NCI Thesaurus ObjectClass-2)
C0237400 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C25417 (NCI Thesaurus ValueDomain-2)
C64658 (NCI Thesaurus ValueDomain-3)
C1880359 (UMLS 2011AA ValueDomain-2)
AgentMissingAmount
Item
Amount of agent missing/not accounted for this period
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C54031 (NCI Thesaurus Property)
C1705492 (UMLS 2011AA Property)
C25417 (NCI Thesaurus Property-2)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C25417 (NCI Thesaurus ValueDomain-2)
C64658 (NCI Thesaurus ValueDomain-3)
C1880359 (UMLS 2011AA ValueDomain-2)
Item
Is the participant compliant with protocol intervention?
text
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C0442711 (UMLS 2011AA ObjectClass)
C25194 (NCI Thesaurus Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C1522602 (UMLS 2011AA ValueDomain-2)
CL.4
Code List
Is the participant compliant with protocol intervention?
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
NoncomplaintReasonText
Item
If No, specify reason for noncompliance
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25638 (NCI Thesaurus Property)
C0392360 (UMLS 2011AA Property)
C25594 (NCI Thesaurus ObjectClass)
C1518422 (UMLS 2011AA ObjectClass)
C25217 (NCI Thesaurus ObjectClass-2)
C1516048 (UMLS 2011AA ObjectClass-2)
Item
Was agent provided at this visit?
text
C25180 (NCI Thesaurus Property)
C1522602 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
CL.5
Code List
Was agent provided at this visit?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (N/A)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
AgentProvidedCurrentVisitAmount
Item
Amount of agent provided at this visit
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25417 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C25417 (NCI Thesaurus ValueDomain-2)
C64658 (NCI Thesaurus ValueDomain-3)
C1880359 (UMLS 2011AA ValueDomain-2)
Item Group
Dcp Template Footer
Protocol Title
Item
Protocol Title
text
C25191 (NCI Thesaurus ValueDomain)
C2986303 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C42774 (NCI Thesaurus Property)
Protocol Version
Item
Protocol Version
text
C25704 (NCI Thesaurus ValueDomain)
C2985700 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Protocol Version Date
Item
Protocol Date
date
C25164 (NCI Thesaurus ValueDomain)
C2985700 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
PageNumber
Item
Page #
float
C25337 (NCI Thesaurus Property)
C0237753 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C0439643 (NCI Metathesaurus ObjectClass)
CaseReportFormTotalPageNumber
Item
Total Page Number
text
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25337 (NCI Thesaurus Property)
C0237753 (UMLS 2011AA Property)
C25304 (NCI Thesaurus Property-2)
C0439810 (UMLS 2011AA Property-2)
C42783 (NCI Thesaurus Property-3)
C1704732 (UMLS 2011AA Property-3)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
DCPTemplateVersionText
Item
DCP Template Version
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C0728990 (NCI Metathesaurus ObjectClass)
C25714 (NCI Thesaurus Property)
C0333052 (UMLS 2011AA Property)
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