ID

2958

Beskrivning

The Division of Cancer Prevention's agent interruption/modification case report form (CRF) template. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5C33C988-5236-20C3-E044-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5C33C988-5236-20C3-E044-0003BA3F9857

Nyckelord

Versioner (2)
  1. 2012-09-19 2012-09-19 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
Uppladdad den

19 september 2012

DOI

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On-Study - Agent Interruption/Modification - 2803972v1.0

Engelsk

No Instruction available.

1 Formulär  
  1. StudyEvent: Agent Interruption/Modification
    1. No Instruction available.
Screening
Beskrivning

Screening

DCP Protocol #
Beskrivning

ProtocolNCIIdentifierNumber

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C19202
UMLS 2011AA Property
C1513882
Institution Code
Beskrivning

NationalCancerInstituteInstituteCode

Datatyp

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
Beskrivning

ParticipantIdentifier

Datatyp

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
Beskrivning

VisitTypeText

Datatyp

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
Beskrivning

VisitDate

Datatyp

date

Alias
NCI Thesaurus Property
C25164
UMLS 2011AA Property
C0011008
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C25716
UMLS 2011AA ObjectClass
C0545082
Agent Interruption/modification Form
Beskrivning

Agent Interruption/modification Form

Interruption Number
Beskrivning

AdditionalAgentInterruptionNumber

Datatyp

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass
C25406
UMLS 2011AA ObjectClass
C1524062
NCI Thesaurus Property
C25542
UMLS 2011AA Property
C1512900
Specify date stopped (MM/DD/YYYY)
Beskrivning

AgentInterruptedDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Metathesaurus Property
C0723457
Specify reason stopped
Beskrivning

AgentDiscontinuedReasonType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Metathesaurus Property
CL212531
Specify reason stopped
Beskrivning

AgentStoppedReasonText

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
Was agent restarted?
Beskrivning

AgentContinuedIndicator

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass
C63536
UMLS 2011AA ObjectClass
C2603343
NCI Thesaurus Property
C25180
UMLS 2011AA Property
C1522602
NCI Thesaurus Property
C53279
UMLS 2011AA Property
C0549178
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
If Yes, specify date restarted (MM/DD/YYYY)
Beskrivning

AgentContinuedDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25658
UMLS 2011AA Property
C1514902
Specify reason restarted
Beskrivning

AgentRestartedReasonType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25658
UMLS 2011AA Property
C1514902
Agent Modifications
Beskrivning

Agent Modifications

Modification Number
Beskrivning

AgentInterruptedModificationorAdjustmentNumber

Datatyp

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Metathesaurus Property
CL212531
NCI Thesaurus ValueDomain
C53606
UMLS 2011AA ValueDomain
C1709057
Specify Date Modified
Beskrivning

AgentModifiedDate

Datatyp

date

Alias
NCI Thesaurus ObjectClass
C25446
UMLS 2011AA ObjectClass
C0392747
NCI Metathesaurus ObjectClass
CL076374
NCI Thesaurus Property
C25164
UMLS 2011AA Property
C0011008
NCI Metathesaurus Property
CL219258
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Specify new regimen dose
Beskrivning

ModifiedDoseAmount

Datatyp

double

Alias
NCI Thesaurus ObjectClass
C25446
UMLS 2011AA ObjectClass
C0392747
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C25417
NCI Thesaurus ValueDomain
C25417
Specify new regimen units
Beskrivning

AgentModifiedUnits

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C25709
UMLS 2011AA Property
C1519795
Specify new regimen frequency
Beskrivning

AgentModifiedFrequency

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25488
UMLS 2011AA Property
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Dcp Template Footer
Beskrivning

Dcp Template Footer

Protocol Title
Beskrivning

ProtocolTitleName

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C42774
UMLS 2011AA Property
C1705823
Protocol Version
Beskrivning

ProtocolVersion

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Protocol Date
Beskrivning

ProtocolVersionDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25367
Page #
Beskrivning

PageNumber

Datatyp

double

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

CaseReportFormTotalPageNumber

Datatyp

text

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

DCPTemplateVersionText

Datatyp

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 Formulär
  1. StudyEvent: Agent Interruption/Modification
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Screening
ProtocolNCIIdentifierNumber
Item
DCP Protocol #
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19202 (NCI Thesaurus Property)
C1513882 (UMLS 2011AA Property)
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)
C25716 (NCI Thesaurus ObjectClass)
C0545082 (UMLS 2011AA ObjectClass)
Item Group
Agent Interruption/modification Form
AdditionalAgentInterruptionNumber
Item
Interruption Number
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25406 (NCI Thesaurus ObjectClass)
C1524062 (UMLS 2011AA ObjectClass)
C25542 (NCI Thesaurus Property)
C1512900 (UMLS 2011AA Property)
AgentInterruptedDate
Item
Specify date stopped (MM/DD/YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C0723457 (NCI Metathesaurus Property)
Item
Specify reason stopped
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
CL212531 (NCI Metathesaurus Property)
CL.1
Code List
Specify reason stopped
CL Item
Investigator Decision, Specify (Investigator decision, specify)
CL Item
Participant Decision, Specify (Participant decision, specify)
CL Item
Ae/sae, Specify (AE/SAE, specify)
CL Item
Other, Specify (Other, specify)
AgentStoppedReasonText
Item
Specify reason stopped
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
Item
Was agent restarted?
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C63536 (NCI Thesaurus ObjectClass)
C2603343 (UMLS 2011AA ObjectClass)
C25180 (NCI Thesaurus Property)
C1522602 (UMLS 2011AA Property)
C53279 (NCI Thesaurus Property)
C0549178 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.2
Code List
Was agent restarted?
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)
AgentContinuedDate
Item
If Yes, specify date restarted (MM/DD/YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25658 (NCI Thesaurus Property)
C1514902 (UMLS 2011AA Property)
Item
Specify reason restarted
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25658 (NCI Thesaurus Property)
C1514902 (UMLS 2011AA Property)
CL.3
Code List
Specify reason restarted
CL Item
Investigator Decision (Investigator decision)
CL Item
Participant Decision (Participant decision)
Item Group
Agent Modifications
AgentInterruptedModificationorAdjustmentNumber
Item
Modification Number
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
CL212531 (NCI Metathesaurus Property)
C53606 (NCI Thesaurus ValueDomain)
C1709057 (UMLS 2011AA ValueDomain)
AgentModifiedDate
Item
Specify Date Modified
date
C25446 (NCI Thesaurus ObjectClass)
C0392747 (UMLS 2011AA ObjectClass)
CL076374 (NCI Metathesaurus ObjectClass)
C25164 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA Property)
CL219258 (NCI Metathesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
ModifiedDoseAmount
Item
Specify new regimen dose
double
C25446 (NCI Thesaurus ObjectClass)
C0392747 (UMLS 2011AA ObjectClass)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25417 (NCI Thesaurus Property)
C25417 (NCI Thesaurus ValueDomain)
AgentModifiedUnits
Item
Specify new regimen units
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25709 (NCI Thesaurus Property)
C1519795 (UMLS 2011AA Property)
AgentModifiedFrequency
Item
Specify new regimen frequency
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus Property)
C0178602 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
Item Group
Dcp Template Footer
ProtocolTitleName
Item
Protocol Title
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C42774 (NCI Thesaurus Property)
C1705823 (UMLS 2011AA Property)
ProtocolVersion
Item
Protocol Version
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ProtocolVersionDate
Item
Protocol Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
PageNumber
Item
Page #
double
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)
C0439810 (UMLS 2011AA Property)
C42783 (NCI Thesaurus Property)
C1704732 (UMLS 2011AA Property)
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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