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  1. StudyEvent: NCI Standard Protocol Deviations Template
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Protocol Deviations Questions
C1705236 (UMLS CUI-1)
Protocol Deviation Notification Date
Item
Protocol Deviation Notification Date
date
C25164 (NCI Thesaurus ValueDomain)
C50996 (NCI Thesaurus ObjectClass)
C25297 (NCI Thesaurus Property)
C1705236 (UMLS CUI [1,1])
C0422202 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Protocol Deviation Occurrence Date
Item
Protocol Deviation Occurrence Date
date
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C50996 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C1705236 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Protocol Deviation Description Text
Item
Protocol Deviation Description
text
C25704 (NCI Thesaurus ValueDomain)
C50996 (NCI Thesaurus ObjectClass)
C0678257 (NCI Metathesaurus Property)
C1705236 (UMLS CUI [1])
Item
Protocol Deviation Severity Type
text
C50996 (NCI Thesaurus ObjectClass)
C25676 (NCI Thesaurus Property)
C25372 (NCI Thesaurus ValueDomain)
C50996 (NCI Thesaurus ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C1705236 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
CL.1
Code List
Protocol Deviation Severity Type
CL Item
Potential To Affect Data Integrity Or Jeopardize Participant Safety (Moderate)
C0205081 (UMLS CUI-1)
CL Item
Will Affect Major Endpoint Data Integrity Or Will Have A Major Impact On Participant Safety Or Ethical Concerns (Major)
C0205164 (UMLS CUI-1)
CL Item
No Meaningful Effect On Data Integrity And No Meaningful Risk To Participant Safety (Minor)
C0205165 (UMLS CUI-1)
Protocol Deviation, other
Item
Protocol Deviation Other Category Descriptive Text
text
C25704 (NCI Thesaurus ValueDomain)
C17649 (NCI Thesaurus Property)
C25372 (NCI Thesaurus Property-2)
C50996 (NCI Thesaurus ObjectClass)
C1705236 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Treating Physician
Item
Treating Physician Or Participating Investigator 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)
C0035173 (UMLS CUI [1])
Item
Protocol Deviation Category
text
C25372 (NCI Thesaurus Property)
C25372 (NCI Thesaurus ValueDomain)
C50996 (NCI Thesaurus ObjectClass)
C50996 (NCI Thesaurus ValueDomain-2)
C1705236 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
CL.2
Code List
Protocol Deviation Category
CL Item
Concomitant Medications: Prohibited Concomitant Medication Was Taken Or Administered (Concomitant Medications)
C2347852 (UMLS CUI-1)
CL Item
Validity And Accuracy Of The Study Data Is Compromised By Either Mishandling, Omitting, Or Falsifying Collected Data. (Data Integrity Compromised)
CL Item
Participant Eligibility Criteria Was Not Fully Verified Before Starting Intervention. (Eligibility not checked)
CL Item
Participant Was Granted A Waiver For Violated Eligibility Criteria Before Or During Trial Intervention. (Eligibility waiver)
CL Item
Informed Consent: Not Collected Or Mishandled (Informed Consent)
C0021430 (UMLS CUI-1)
CL Item
Other, Specify: Deviation Does Not Fit Into Types Listed (Other, specify)
C3845569 (UMLS CUI-1)
CL Item
Study Procedures: Other Study Procedures, Such As Labs, Images, Missed Or Out Of The Window From That Described In The Protocol (Study Procedures)
CL Item
Treatment: Study Drug Agent/intervention Not Given As Directed In The Protocol (Treatment)
C0087111 (UMLS CUI-1)
Protocol Deviation Action Text
Item
Protocol Deviation Action Text
text
C25704 (NCI Thesaurus ValueDomain)
C50996 (NCI Thesaurus ObjectClass)
C25404 (NCI Thesaurus Property)
C1705236 (UMLS CUI [1])
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