ID

3460

Description

The Division of Cancer Prevention's AE and conmed evaluation case report form (CRF) template. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5C1255DF-0CBA-43D9-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5C1255DF-0CBA-43D9-E044-0003BA3F9857

Keywords

Versions (2)
  1. 9/20/12 9/20/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

September 20, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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On-Study - AE and Conmed Evaluation - 2803423v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: AE and Conmed Evaluation
    1. No Instruction available.
Screening
Description

Screening

DCP Protocol #
Description

ProtocolNCIIdentifierNumber

Data type

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
Description

NationalCancerInstituteInstituteCode

Data type

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
Description

ParticipantIdentifier

Data type

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
Ae And Conmed Evaluation Form
Description

Ae And Conmed Evaluation Form

Visit Type
Description

ConcomitantAgentAdverseEventVisitType

Data type

text

Alias
NCI Thesaurus ObjectClass
C25716
UMLS 2011AA ObjectClass
C0545082
NCI Thesaurus Property
C25284
UMLS 2011AA Property
C0332307
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
NCI Thesaurus ValueDomain
C70902
UMLS 2011AA ValueDomain
C2347852
NCI Thesaurus ValueDomain
C25716
UMLS 2011AA ValueDomain
C0545082
Visit Date (MM/DD/YYYY)
Description

VisitDate

Data type

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
Not Obtained
Description

NotObtainedIndicator

Data type

text

Alias
NCI Thesaurus Property
C25180
UMLS 2011AA Property
C1522602
NCI Metathesaurus ObjectClass
CL310460
NCI Metathesaurus ObjectClass
CL052458
NCI Metathesaurus ValueDomain
C0021212
Were any new or changes in Adverse Events reported? (either the first report of a new AE or changes to previously reported AEs? - Footnote - If Yes is selected; the Adverse Event form must be completed. If No and/or N/A is selected for ALL visits, NONE must be checked on the AE form)
Description

NewOrChangeAdverseEventReportedIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass
C37998
UMLS 2011AA ObjectClass
C1518602
NCI Thesaurus ObjectClass
C25446
UMLS 2011AA ObjectClass
C0392747
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Were any new or changes in Concomitant Medications reported? (either the first report of a new Conmed or changes to previously reported Conmed? - Footnote - If Yes is selected; the Concomitant Medication form must be completed. If No and/or N/A is selected for ALL visits, NONE must be selected on the Concomitant Medication form)
Description

NewOrChangeConcomitantMedicationReportedIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass
C37998
UMLS 2011AA ObjectClass
C1518602
NCI Thesaurus ObjectClass
C25446
UMLS 2011AA ObjectClass
C0392747
NCI Thesaurus ObjectClass
C25730
UMLS 2011AA ObjectClass
C0521115
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ValueDomain
C25586
UMLS 2011AA ValueDomain
C0205314
NCI Thesaurus ValueDomain
C37998
UMLS 2011AA ValueDomain
C1518602
NCI Thesaurus ValueDomain
C25446
UMLS 2011AA ValueDomain
C0392747
NCI Thesaurus ValueDomain
C70902
UMLS 2011AA ValueDomain
C2347852
Dcp Template Footer
Description

Dcp Template Footer

Protocol Title
Description

ProtocolTitleName

Data type

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
Description

ProtocolVersion

Data type

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
Description

ProtocolVersionDate

Data type

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 #
Description

PageNumber

Data type

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
Description

CaseReportFormTotalPageNumber

Data type

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
Description

DCPTemplateVersionText

Data type

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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No Instruction available.

1 forms
  1. StudyEvent: AE and Conmed Evaluation
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
Item Group
Ae And Conmed Evaluation Form
Item
Visit Type
text
C25716 (NCI Thesaurus ObjectClass)
C0545082 (UMLS 2011AA ObjectClass)
C25284 (NCI Thesaurus Property)
C0332307 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C70902 (NCI Thesaurus ValueDomain)
C2347852 (UMLS 2011AA ValueDomain)
C25716 (NCI Thesaurus ValueDomain)
C0545082 (UMLS 2011AA ValueDomain)
CL.1
Code List
Visit Type
CL Item
Registration/randomization (Registration/Randomization)
CL Item
Month 1 (Month 1)
CL Item
Month 2 (Month 2)
CL Item
Month 3 (Month 3)
CL Item
Month 4 (Month 4)
CL Item
Month 5 (Month 5)
CL Item
Month 6 (Month 6)
CL Item
Follow Up (Follow up)
VisitDate
Item
Visit Date (MM/DD/YYYY)
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
Not Obtained
text
C25180 (NCI Thesaurus Property)
C1522602 (UMLS 2011AA Property)
CL310460 (NCI Metathesaurus ObjectClass)
CL052458 (NCI Metathesaurus ObjectClass)
C0021212 (NCI Metathesaurus ValueDomain)
CL.2
Code List
Not Obtained
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
Were any new or changes in Adverse Events reported? (either the first report of a new AE or changes to previously reported AEs? - Footnote - If Yes is selected; the Adverse Event form must be completed. If No and/or N/A is selected for ALL visits, NONE must be checked on the AE form)
text
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C37998 (NCI Thesaurus ObjectClass)
C1518602 (UMLS 2011AA ObjectClass)
C25446 (NCI Thesaurus ObjectClass)
C0392747 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.3
Code List
Were any new or changes in Adverse Events reported? (either the first report of a new AE or changes to previously reported AEs? - Footnote - If Yes is selected; the Adverse Event form must be completed. If No and/or N/A is selected for ALL visits, NONE must be checked on the AE form)
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)
Item
Were any new or changes in Concomitant Medications reported? (either the first report of a new Conmed or changes to previously reported Conmed? - Footnote - If Yes is selected; the Concomitant Medication form must be completed. If No and/or N/A is selected for ALL visits, NONE must be selected on the Concomitant Medication form)
text
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C37998 (NCI Thesaurus ObjectClass)
C1518602 (UMLS 2011AA ObjectClass)
C25446 (NCI Thesaurus ObjectClass)
C0392747 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass)
C0521115 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ValueDomain)
C0205314 (UMLS 2011AA ValueDomain)
C37998 (NCI Thesaurus ValueDomain)
C1518602 (UMLS 2011AA ValueDomain)
C25446 (NCI Thesaurus ValueDomain)
C0392747 (UMLS 2011AA ValueDomain)
C70902 (NCI Thesaurus ValueDomain)
C2347852 (UMLS 2011AA ValueDomain)
CL.4
Code List
Were any new or changes in Concomitant Medications reported? (either the first report of a new Conmed or changes to previously reported Conmed? - Footnote - If Yes is selected; the Concomitant Medication form must be completed. If No and/or N/A is selected for ALL visits, NONE must be selected on the Concomitant Medication form)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Evaluated (Not Evaluated)
CL Item
Not Applicable (N/A)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
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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