ID

1489

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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27 augustus 2012

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Creative Commons BY-NC 3.0
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COMMON - NCI Standard Protocol Deviations Template - 2750875v1.0

Engels

No Instruction available.

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

Conditional Protocol Deviations Questions

Protocol Deviation Notification Date (Enter the date the local study team and/or site PI became aware of the deviation.)
Beschrijving

ProtocolDeviationNotificationDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C50996
UMLS 2011AA ObjectClass
C1705236
NCI Thesaurus Property
C25297
UMLS 2011AA Property
C0422202
Optional Protocol Deviations Questions
Beschrijving

Optional Protocol Deviations Questions

Protocol Deviation Occurrence Date (Enter the date on which the protocol deviation occurred.)
Beschrijving

ProtocolDeviationOccurrenceDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C50996
UMLS 2011AA ObjectClass
C1705236
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Protocol Deviation Description (Enter a description of the protocol deviation including reasons and contributing factors.)
Beschrijving

ProtocolDeviationDescriptionText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C50996
UMLS 2011AA ObjectClass
C1705236
NCI Metathesaurus Property
C0678257
Protocol Deviation Severity Type (Select categorization to indicate a level of severity for the deviation.)
Beschrijving

ProtocolDeviationSeverityType

Datatype

text

Alias
NCI Thesaurus ObjectClass
C50996
UMLS 2011AA ObjectClass
C1705236
NCI Thesaurus Property
C25676
UMLS 2011AA Property
C0439793
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ValueDomain
C50996
UMLS 2011AA ValueDomain
C1705236
NCI Thesaurus ValueDomain
C25676
UMLS 2011AA ValueDomain
C0439793
Protocol Deviation Other Category Descriptive Text (Enter Other protocol category. Enter only when Deviation Category choice list "Other" was selected.)
Beschrijving

ProtocolDeviationOtherCategoryDescriptiveText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C25372
UMLS 2011AA Property
C0683312
NCI Thesaurus ObjectClass
C50996
UMLS 2011AA ObjectClass
C1705236
Treating Physician Or Participating Investigator Name (Enter the participating investigator or treating physician name.)
Beschrijving

TreatingPhysicianOrParticipatingInvestigatorName

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25608
UMLS 2011AA ObjectClass
C0679823
NCI Thesaurus ObjectClass
C37998
UMLS 2011AA ObjectClass
C1518602
NCI Thesaurus ObjectClass
C51883
UMLS 2011AA ObjectClass
C1710470
NCI Thesaurus ObjectClass
C25936
UMLS 2011AA ObjectClass
C0035173
NCI Thesaurus Property
C25191
UMLS 2011AA Property
C1547383
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Protocol Deviation Category (Select the category to classify the deviation.)
Beschrijving

ProtocolDeviationCategory

Datatype

text

Alias
NCI Thesaurus Property
C25372
UMLS 2011AA Property
C0683312
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C50996
UMLS 2011AA ObjectClass
C1705236
NCI Thesaurus ValueDomain
C50996
UMLS 2011AA ValueDomain
C1705236
Protocol Deviation Action Text (Describe the actions initiated by the site to prevent the reoccurrence of the protocol deviation.)
Beschrijving

ProtocolDeviationActionText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C50996
UMLS 2011AA ObjectClass
C1705236
NCI Thesaurus Property
C25404
UMLS 2011AA Property
C0441472
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Similar models

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
Conditional Protocol Deviations Questions
ProtocolDeviationNotificationDate
Item
Protocol Deviation Notification Date (Enter the date the local study team and/or site PI became aware of the deviation.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C50996 (NCI Thesaurus ObjectClass)
C1705236 (UMLS 2011AA ObjectClass)
C25297 (NCI Thesaurus Property)
C0422202 (UMLS 2011AA Property)
Item Group
Optional Protocol Deviations Questions
ProtocolDeviationOccurrenceDate
Item
Protocol Deviation Occurrence Date (Enter the date on which the protocol deviation occurred.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C50996 (NCI Thesaurus ObjectClass)
C1705236 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
ProtocolDeviationDescriptionText
Item
Protocol Deviation Description (Enter a description of the protocol deviation including reasons and contributing factors.)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C50996 (NCI Thesaurus ObjectClass)
C1705236 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)
Item
Protocol Deviation Severity Type (Select categorization to indicate a level of severity for the deviation.)
text
C50996 (NCI Thesaurus ObjectClass)
C1705236 (UMLS 2011AA ObjectClass)
C25676 (NCI Thesaurus Property)
C0439793 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C50996 (NCI Thesaurus ValueDomain)
C1705236 (UMLS 2011AA ValueDomain)
C25676 (NCI Thesaurus ValueDomain)
C0439793 (UMLS 2011AA ValueDomain)
CL.1
Code List
Protocol Deviation Severity Type (Select categorization to indicate a level of severity for the deviation.)
CL Item
Potential To Affect Data Integrity Or Jeopardize Participant Safety (Moderate)
CL Item
Will Affect Major Endpoint Data Integrity Or Will Have A Major Impact On Participant Safety Or Ethical Concerns (Major)
CL Item
No Meaningful Effect On Data Integrity And No Meaningful Risk To Participant Safety (Minor)
ProtocolDeviationOtherCategoryDescriptiveText
Item
Protocol Deviation Other Category Descriptive Text (Enter Other protocol category. Enter only when Deviation Category choice list "Other" was selected.)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25372 (NCI Thesaurus Property)
C0683312 (UMLS 2011AA Property)
C50996 (NCI Thesaurus ObjectClass)
C1705236 (UMLS 2011AA ObjectClass)
TreatingPhysicianOrParticipatingInvestigatorName
Item
Treating Physician Or Participating Investigator Name (Enter the participating investigator or treating physician name.)
text
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C37998 (NCI Thesaurus ObjectClass)
C1518602 (UMLS 2011AA ObjectClass)
C51883 (NCI Thesaurus ObjectClass)
C1710470 (UMLS 2011AA ObjectClass)
C25936 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C25191 (NCI Thesaurus Property)
C1547383 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
Item
Protocol Deviation Category (Select the category to classify the deviation.)
text
C25372 (NCI Thesaurus Property)
C0683312 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C50996 (NCI Thesaurus ObjectClass)
C1705236 (UMLS 2011AA ObjectClass)
C50996 (NCI Thesaurus ValueDomain)
C1705236 (UMLS 2011AA ValueDomain)
CL.2
Code List
Protocol Deviation Category (Select the category to classify the deviation.)
CL Item
Concomitant Medications: Prohibited Concomitant Medication Was Taken Or Administered (Concomitant Medications)
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)
CL Item
Other, Specify: Deviation Does Not Fit Into Types Listed (Other, specify)
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)
ProtocolDeviationActionText
Item
Protocol Deviation Action Text (Describe the actions initiated by the site to prevent the reoccurrence of the protocol deviation.)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C50996 (NCI Thesaurus ObjectClass)
C1705236 (UMLS 2011AA ObjectClass)
C25404 (NCI Thesaurus Property)
C0441472 (UMLS 2011AA Property)
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