ID

22841

Description

AMC-061 Protocol Deviation Form (DEV) Sunitinib Malate in Treating HIV-Positive Patients With Cancer Receiving Antiretroviral Therapy https://clinicaltrials.gov/ct2/show/NCT00890747

Link

https://clinicaltrials.gov/ct2/show/NCT00890747

Keywords

Versions (2)
  1. 8/26/12 8/26/12 -
  2. 6/12/17 6/12/17 - Martin Dugas
Uploaded on

June 12, 2017

DOI

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License

Creative Commons BY 4.0
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HIV Cancer Sunitinib NCT00890747 AMC-061

English

No Instruction available.

1 forms  
  1. StudyEvent: AMC-061 Protocol Deviation Form (DEV)
    1. No Instruction available.
Header Module
Description

Header Module

Alias
UMLS CUI-1
C1320722
AMC Protocol Number
Description

Protocol AIDS Malignancy Consortium Identifier Number

Data type

text

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

Protocol Deviation Occurrence Date

Data type

date

Measurement units
  • mm/dd/yyyy
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C50996
NCI Thesaurus Property
C25275
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0011008
mm/dd/yyyy
Specify deviation
Description

Protocol Deviation Description Text

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

Protocol Deviation Description Text

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ObjectClass
C50996
NCI Metathesaurus Property
C0678257
UMLS CUI [1]
C1705236
Action Taken (What steps were taken to resolve this deviation)
Description

Protocol Deviation Action Text

Data type

text

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

Protocol Deviation Specified Participant Associated

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C50996
NCI Thesaurus Property
C29867
NCI Thesaurus Property
C25281
NCI Thesaurus Property
C38024
NCI Thesaurus ValueDomain
C38148
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0679646
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

Protocol Deviation Adverse Event Associated

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus Property
C41331
NCI Thesaurus ObjectClass
C50996
NCI Thesaurus Property
C25281
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0877248
Is the participant still being followed (will the participant continue in the study)
Description

Patient Viable Follow-Up

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C16033
NCI Thesaurus Property
C25324
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1522577
Participating Investigator or Physician Name
Description

printed investigator name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass
C37998
NCI Thesaurus ObjectClass
C51883
NCI Thesaurus ObjectClass
C25936
NCI Thesaurus Property
C25191
NCI Thesaurus ValueDomain
C25191
UMLS CUI [1]
C1710470
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Similar models

No Instruction available.

1 forms
  1. StudyEvent: AMC-061 Protocol Deviation Form (DEV)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
C1320722 (UMLS CUI-1)
Protocol AIDS Malignancy Consortium Identifier Number
Item
AMC Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C19707 (NCI Thesaurus Property)
C1507394 (UMLS CUI [1,1])
C1515830 (UMLS CUI [1,2])
Protocol Deviation Occurrence Date
Item
Date Protocol Deviation Occurred
date
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C50996 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C1705236 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Protocol Deviation Description Text
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)
Protocol Deviation Description Text
Item
Protocol Deviation Description (Reason for deviation from the protocol)
text
C25704 (NCI Thesaurus ValueDomain)
C50996 (NCI Thesaurus ObjectClass)
C0678257 (NCI Metathesaurus Property)
C1705236 (UMLS CUI [1])
Protocol Deviation Action Text
Item
Action Taken (What steps were taken to resolve this deviation)
text
C25704 (NCI Thesaurus ValueDomain)
C50996 (NCI Thesaurus ObjectClass)
C25404 (NCI Thesaurus Property)
C1705236 (UMLS CUI [1,1])
C0441472 (UMLS CUI [1,2])
Protocol Deviation Specified Participant Associated
Item
Is the protocol deviation associated with a particular participant
boolean
C50996 (NCI Thesaurus ObjectClass)
C29867 (NCI Thesaurus Property)
C25281 (NCI Thesaurus Property)
C38024 (NCI Thesaurus Property)
C38148 (NCI Thesaurus ValueDomain)
C1705236 (UMLS CUI [1,1])
C0679646 (UMLS CUI [1,2])
Participant Identifier
Item
Participant ID
text
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25364 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI [1])
Protocol Deviation Adverse Event Associated
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)
C1705236 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Patient Viable Follow-Up
Item
Is the participant still being followed (will the participant continue in the study)
boolean
C38148 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C16033 (NCI Thesaurus Property)
C25324 (NCI Thesaurus Property)
C0030705 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
Treating Physician Or Participating Investigator Name
Item
Participating Investigator or Physician Name
text
C25608 (NCI Thesaurus ObjectClass)
C37998 (NCI Thesaurus ObjectClass)
C51883 (NCI Thesaurus ObjectClass)
C25936 (NCI Thesaurus ObjectClass)
C25191 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C1710470 (UMLS CUI [1])
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