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1 forms  
  1. StudyEvent: AMC-063 Protocol Deviation Form (DEV)
    1. No Instruction available.
Header - Protocol Deviation Form
Description

Header - Protocol Deviation Form

Alias
UMLS CUI-1
C1320722
UMLS CUI-2
C1705236
UMLS CUI-3
C0276535
AMC Protocol Number
Description

ProtocolAIDSMalignancyConsortiumIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C25320
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C19707
UMLS CUI [1,1]
C1507394
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C1515830
Date Protocol Deviation Occurred
Description

Protocol Deviation Occurrence Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C50996
NCI Thesaurus Property
C25275
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0011008
Specify deviation
Description

Protocol Deviation Description

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ObjectClass
C50996
NCI Thesaurus Property
C25365
UMLS CUI [1]
C1705236
Protocol Deviation Information
Description

Protocol Deviation Information

Alias
UMLS CUI-1
C1705236
UMLS CUI-2
C0276535
Protocol Deviation Description
Description

Protocol Deviation Description

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ObjectClass
C50996
NCI Metathesaurus Property
C0678257
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0678257
Action Taken
Description

Action Taken

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ObjectClass
C50996
NCI Thesaurus Property
C25404
UMLS CUI [1,1]
C0441472
UMLS CUI [1,2]
C1705236
Is the protocol deviation associated with a particular participant
Description

ProtocolDeviationSpecifiedParticipantAssociatedInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C50996
NCI Thesaurus Property
C29867
NCI Thesaurus Property-2
C25281
NCI Thesaurus Property-3
C38024
NCI Thesaurus ValueDomain
C38148
UMLS CUI [1,1]
C0679646
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C1705236
Participant ID
Description

Participant Identifier

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25364
UMLS CUI [1]
C2348585
Did the protocol deviation result in an adverse event
Description

ProtocolDeviationAdverseEventAssociatedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus Property
C41331
NCI Thesaurus ObjectClass
C50996
NCI Thesaurus Property-2
C25281
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1705236
Is the participant still being followed
Description

PatientViableFollow-UpInd-3 (will the participant continue in the study)

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C16033
NCI Thesaurus Property-2
C25324
UMLS CUI [1,1]
C0679646
UMLS CUI [1,2]
C1522577
Participating Investigator or Physician Name
Description

TreatingPhysicianOrParticipatingInvestigatorName (printed investigator name)

Data type

text

Alias
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C37998
NCI Thesaurus ObjectClass-3
C51883
NCI Thesaurus ObjectClass-4
C25936
NCI Thesaurus Property
C25191
NCI Thesaurus ValueDomain
C25191
UMLS CUI [1]
C1710470
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1 forms
  1. StudyEvent: AMC-063 Protocol Deviation Form (DEV)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header - Protocol Deviation Form
C1320722 (UMLS CUI-1)
C1705236 (UMLS CUI-2)
C0276535 (UMLS CUI-3)
AMC Protocol Number
Item
AMC Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C19707 (NCI Thesaurus Property-2)
C1507394 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C1515830 (UMLS CUI [1,3])
Protocol Deviation Occurrence Date
Item
Date Protocol Deviation Occurred
date
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C50996 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C1705236 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Protocol Deviation Description
Item
Specify deviation
text
C25704 (NCI Thesaurus ValueDomain)
C50996 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property)
C1705236 (UMLS CUI [1])
Item Group
Protocol Deviation Information
C1705236 (UMLS CUI-1)
C0276535 (UMLS CUI-2)
Protocol Deviation Description
Item
Protocol Deviation Description
text
C25704 (NCI Thesaurus ValueDomain)
C50996 (NCI Thesaurus ObjectClass)
C0678257 (NCI Metathesaurus Property)
C1705236 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Action Taken
Item
Action Taken
text
C25704 (NCI Thesaurus ValueDomain)
C50996 (NCI Thesaurus ObjectClass)
C25404 (NCI Thesaurus Property)
C0441472 (UMLS CUI [1,1])
C1705236 (UMLS CUI [1,2])
protocol deviation associated with a particular participant
Item
Is the protocol deviation associated with a particular participant
boolean
C50996 (NCI Thesaurus ObjectClass)
C29867 (NCI Thesaurus Property)
C25281 (NCI Thesaurus Property-2)
C38024 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)
C0679646 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
Participant Identifier
Item
Participant ID
text
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25364 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI [1])
protocol deviation result in an adverse event
Item
Did the protocol deviation result in an adverse event
boolean
C38148 (NCI Thesaurus ValueDomain)
C41331 (NCI Thesaurus Property)
C50996 (NCI Thesaurus ObjectClass)
C25281 (NCI Thesaurus Property-2)
C0877248 (UMLS CUI [1,1])
C1705236 (UMLS CUI [1,2])
Is the participant still being followed
Item
Is the participant still being followed
boolean
C38148 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C16033 (NCI Thesaurus Property)
C25324 (NCI Thesaurus Property-2)
C0679646 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
Participating Investigator or Physician Name
Item
Participating Investigator or Physician Name
text
C25608 (NCI Thesaurus ObjectClass)
C37998 (NCI Thesaurus ObjectClass-2)
C51883 (NCI Thesaurus ObjectClass-3)
C25936 (NCI Thesaurus ObjectClass-4)
C25191 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C1710470 (UMLS CUI [1])
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