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  1. StudyEvent: AMC-061 Protocol Deviation Form (DEV)
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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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