ID

2765

Beschrijving

AMC-063 Protocol Deviation Form (DEV) Bortezomib in Treating Patients With Relapsed or Refractory AIDS-Related Kaposi Sarcoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=83BE8F76-504C-7466-E040-BB89AD4317E3

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=83BE8F76-504C-7466-E040-BB89AD4317E3

Trefwoorden

Versies (2)
  1. 19-09-12 19-09-12 -
  2. 20-09-17 20-09-17 -
Geüploaded op

19 september 2012

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Sarcoma NCT01016730 On-Study - AMC-063 Protocol Deviation Form (DEV) - 3055985v1.0

Engels

No Instruction available.

1 Formulieren  
  1. StudyEvent: AMC-063 Protocol Deviation Form (DEV)
    1. No Instruction available.
Header Module
Beschrijving

Header Module

AMC Protocol Number
Beschrijving

ProtocolAIDSMalignancyConsortiumIdentifierNumber

Datatype

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
C19707
UMLS 2011AA Property
C1515830
Date Protocol Deviation Occurred (mm/dd/yyyy)
Beschrijving

ProtocolDeviationOccurrenceDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C50996
UMLS 2011AA ObjectClass
C1705236
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Specify deviation
Beschrijving

ProtocolDeviationDescriptionText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C50996
UMLS 2011AA ObjectClass
C1705236
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Protocol Deviation Information
Beschrijving

Protocol Deviation Information

Protocol Deviation Description (Reason for deviation from the protocol)
Beschrijving

ProtocolDeviationDescriptionText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C50996
UMLS 2011AA ObjectClass
C1705236
NCI Metathesaurus Property
C0678257
Action Taken (What steps were taken to resolve this deviation)
Beschrijving

ProtocolDeviationActionText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C50996
UMLS 2011AA ObjectClass
C1705236
NCI Thesaurus Property
C25404
UMLS 2011AA Property
C0441472
Is the protocol deviation associated with a particular participant
Beschrijving

ProtocolDeviationSpecifiedParticipantAssociatedInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C50996
UMLS 2011AA ObjectClass
C1705236
NCI Thesaurus Property
C29867
UMLS 2011AA Property
C0679646
NCI Thesaurus Property
C25281
UMLS 2011AA Property
C0332281
NCI Thesaurus Property
C38024
UMLS 2011AA Property
C0205369
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Participant ID
Beschrijving

ParticipantIdentifier

Datatype

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
Did the protocol deviation result in an adverse event
Beschrijving

ProtocolDeviationAdverseEventAssociatedInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C41331
UMLS 2011AA Property
C0877248
NCI Thesaurus ObjectClass
C50996
UMLS 2011AA ObjectClass
C1705236
NCI Thesaurus Property
C25281
UMLS 2011AA Property
C0332281
Is the participant still being followed (will the participant continue in the study)
Beschrijving

PatientViableFollow-UpInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus Property
C25324
UMLS 2011AA Property
C0443348
Participating Investigator or Physician Name (printed investigator name)
Beschrijving

TreatingPhysicianOrParticipatingInvestigatorName

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25608
UMLS 2011AA ObjectClass
C0679823
NCI Thesaurus ObjectClass
C37998
UMLS 2011AA ObjectClass
C1518602
NCI Thesaurus ObjectClass
C51883
UMLS 2011AA ObjectClass
C1710470
NCI Thesaurus ObjectClass
C25936
UMLS 2011AA ObjectClass
C0035173
NCI Thesaurus Property
C25191
UMLS 2011AA Property
C1547383
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
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Similar models

No Instruction available.

1 Formulieren
  1. StudyEvent: AMC-063 Protocol Deviation Form (DEV)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Header Module
ProtocolAIDSMalignancyConsortiumIdentifierNumber
Item
AMC Protocol Number
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)
C19707 (NCI Thesaurus Property)
C1515830 (UMLS 2011AA Property)
ProtocolDeviationOccurrenceDate
Item
Date Protocol Deviation Occurred (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C50996 (NCI Thesaurus ObjectClass)
C1705236 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
ProtocolDeviationDescriptionText
Item
Specify deviation
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C50996 (NCI Thesaurus ObjectClass)
C1705236 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item Group
Protocol Deviation Information
ProtocolDeviationDescriptionText
Item
Protocol Deviation Description (Reason for deviation from the protocol)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C50996 (NCI Thesaurus ObjectClass)
C1705236 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)
ProtocolDeviationActionText
Item
Action Taken (What steps were taken to resolve this deviation)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C50996 (NCI Thesaurus ObjectClass)
C1705236 (UMLS 2011AA ObjectClass)
C25404 (NCI Thesaurus Property)
C0441472 (UMLS 2011AA Property)
Item
Is the protocol deviation associated with a particular participant
text
C50996 (NCI Thesaurus ObjectClass)
C1705236 (UMLS 2011AA ObjectClass)
C29867 (NCI Thesaurus Property)
C0679646 (UMLS 2011AA Property)
C25281 (NCI Thesaurus Property)
C0332281 (UMLS 2011AA Property)
C38024 (NCI Thesaurus Property)
C0205369 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.1
Code List
Is the protocol deviation associated with a particular participant
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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
Did the protocol deviation result in an adverse event
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus Property)
C0877248 (UMLS 2011AA Property)
C50996 (NCI Thesaurus ObjectClass)
C1705236 (UMLS 2011AA ObjectClass)
C25281 (NCI Thesaurus Property)
C0332281 (UMLS 2011AA Property)
CL.2
Code List
Did the protocol deviation result in an adverse event
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Is the participant still being followed (will the participant continue in the study)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25324 (NCI Thesaurus Property)
C0443348 (UMLS 2011AA Property)
CL.3
Code List
Is the participant still being followed (will the participant continue in the study)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
TreatingPhysicianOrParticipatingInvestigatorName
Item
Participating Investigator or Physician Name (printed investigator name)
text
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C37998 (NCI Thesaurus ObjectClass)
C1518602 (UMLS 2011AA ObjectClass)
C51883 (NCI Thesaurus ObjectClass)
C1710470 (UMLS 2011AA ObjectClass)
C25936 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C25191 (NCI Thesaurus Property)
C1547383 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
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