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ID

23817

Beschrijving

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

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Versies (2)
  1. 27-08-12 27-08-12 -
  2. 14-07-17 14-07-17 - Martin Dugas
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14 juli 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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    NCI Standard Protocol Deviations Template

    Engels

    No Instruction available.

    1 Formulieren  
    1. StudyEvent: NCI Standard Protocol Deviations Template
      1. No Instruction available.
    Protocol Deviations Questions
    Beschrijving

    Protocol Deviations Questions

    Alias
    UMLS CUI-1
    C1705236
    Protocol Deviation Notification Date
    Beschrijving

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

    Datatype

    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
    Beschrijving

    Enter the date on which the protocol deviation occurred.

    Datatype

    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
    Beschrijving

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

    Datatype

    text

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

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

    Datatype

    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
    Beschrijving

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

    Datatype

    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
    Beschrijving

    Enter the participating investigator or treating physician name.

    Datatype

    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
    Beschrijving

    Select the category to classify the deviation.

    Datatype

    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
    Beschrijving

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

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    NCI Thesaurus ObjectClass
    C50996
    NCI Thesaurus Property
    C25404
    UMLS CUI [1]
    C1705236
    Terug naar het begin van de pagina

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    No Instruction available.

    1 Formulieren
    1. StudyEvent: NCI Standard Protocol Deviations Template
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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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