ID

23817

Description

The collection of CDEs used in the protocol deviations module. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4DA99369-4E65-7200-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4DA99369-4E65-7200-E044-0003BA3F9857

Keywords

Versions (2)
  1. 8/27/12 8/27/12 -
  2. 7/14/17 7/14/17 - Martin Dugas
Uploaded on

July 14, 2017

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License

Creative Commons BY-NC 3.0
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NCI Standard Protocol Deviations Template

English

No Instruction available.

1 forms  
  1. StudyEvent: NCI Standard Protocol Deviations Template
    1. No Instruction available.
Protocol Deviations Questions
Description

Protocol Deviations Questions

Alias
UMLS CUI-1
C1705236
Protocol Deviation Notification Date
Description

Enter the date the local study team and/or site PI became aware of the deviation.

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C50996
NCI Thesaurus Property
C25297
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0422202
UMLS CUI [1,3]
C0011008
Protocol Deviation Occurrence Date
Description

Enter the date on which the protocol deviation occurred.

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]
C2745955
UMLS CUI [1,3]
C0011008
Protocol Deviation Description
Description

Enter a description of the protocol deviation including reasons and contributing factors.

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ObjectClass
C50996
NCI Metathesaurus Property
C0678257
UMLS CUI [1]
C1705236
Protocol Deviation Severity Type
Description

Select categorization to indicate a level of severity for the deviation.

Data type

text

Alias
NCI Thesaurus ObjectClass
C50996
NCI Thesaurus Property
C25676
NCI Thesaurus ValueDomain
C25372
NCI Thesaurus ValueDomain-2
C50996
NCI Thesaurus ValueDomain-3
C25676
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0439793
Protocol Deviation Other Category Descriptive Text
Description

Enter Other protocol category. Enter only when Deviation Category choice list "Other" was selected.

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus Property
C17649
NCI Thesaurus Property-2
C25372
NCI Thesaurus ObjectClass
C50996
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0205394
Treating Physician Or Participating Investigator Name
Description

Enter the participating investigator or treating physician 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]
C0035173
Protocol Deviation Category
Description

Select the category to classify the deviation.

Data type

text

Alias
NCI Thesaurus Property
C25372
NCI Thesaurus ValueDomain
C25372
NCI Thesaurus ObjectClass
C50996
NCI Thesaurus ValueDomain-2
C50996
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0683312
Protocol Deviation Action Text
Description

Describe the actions initiated by the site to prevent the reoccurrence of the protocol deviation.

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ObjectClass
C50996
NCI Thesaurus Property
C25404
UMLS CUI [1]
C1705236
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Similar models

No Instruction available.

1 forms
  1. StudyEvent: NCI Standard Protocol Deviations Template
    1. No Instruction available.
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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