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Long NameProtocol Deviations NCI Standard Template
DefinitionThe collection of CDEs used in the protocol deviations module.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowRELEASED
TypeCRF
Public ID2750875
Version1.0
Module Long NameModule InstructionsQuestionCDECDE Public IDCDE VersionQuestion InstructionsValue Domain Long NameValue Domain Data TypeValue Domain Unit of MeasureDisplay FormatValid ValueForm Value Meaning TextForm Value Meaning Desc.
Conditional Protocol Deviations QuestionsA data collection variable that must be collected on the CRF for specific cases that may be dictated by local or sponsor defined business rules.
Protocol Deviation Notification DateProtocol Deviation Notification Date24350091.1Enter the date the local study team and/or site PI became aware of the deviation. Conditionality Rule: Condition is for use in multi-site trials, or when multiple teams may be involved in the conduct of a trial.DateDATEMM/DD/YYYY
Optional Protocol Deviations QuestionsA data collection variable that is available for use if needed. There is no regulatory or business requirement for inclusion of this element on the CRF.
Protocol Deviation Occurrence DateProtocol Deviation Occurrence Date24349981.0Enter the date on which the protocol deviation occurred.DateDATEMM/DD/YYYY
Protocol Deviation DescriptionProtocol Deviation Description Text24350381.0Enter a description of the protocol deviation including reasons and contributing factors.Protocol Deviation Description TextCHARACTER
Protocol Deviation Severity TypeProtocol Deviation Severity Type27404011.0Select categorization to indicate a level of severity for the deviation.Protocol Deviation Severity CategoryCHARACTER
ModeratePotential to affect data integrity or jeopardize participant safetyModerate deviation with the potential to affect data integrity or jeopardize participant safety
MajorWill affect major endpoint data integrity or will have a major impact on participant safety or ethical concernsMajor deviation that will affect major endpoint data integrity or will have a major impact on participant safety or ethical concerns
MinorNo meaningful effect on data integrity and no meaningful risk to participant safetyMinor protocol deviation with no meaningful effect on data integrity and no meaningful risk to participant safety
Protocol Deviation Other Category Descriptive TextProtocol Deviation Other Category Descriptive Text27404191.0Enter Other protocol category. Enter only when Deviation Category choice list "Other" was selected.Descriptive TextALPHANUMERIC
Treating Physician Or Participating Investigator NameTreating Physician Or Participating Investigator Name27404241.0Enter the participating investigator or treating physician name.Individuals NameCHARACTER
Protocol Deviation CategoryProtocol Deviation Category27404121.0Select the category to classify the deviation.Protocol Deviation CategoryCHARACTER
Concomitant MedicationsConcomitant Medications: prohibited concomitant medication was taken or administeredConcomitant medications prohibited by protocol taken or administered
Data Integrity CompromisedValidity and accuracy of the study data is compromised by either mishandling, omitting, or falsifying collected data.Validity and accuracy of the study data is compromised by either mishandling, omitting, or falsifying collected data.
Eligibility not checkedParticipant eligibility criteria was not fully verified before starting intervention.Participant eligibility criteria was not fully verified before starting intervention.
Eligibility waiverParticipant was granted a waiver for violated eligibility criteria before or during trial intervention.Participant was granted a waiver for violated eligibility criteria before or during trial intervention.
Informed ConsentInformed Consent: not collected or mishandledInformed Consent was not collected or mishandled
Other, specifyOther, specify: deviation does not fit into types listedOther deviation that does not fit into categories listed
Study ProceduresStudy Procedures: other study procedures, such as labs, images, missed or out of the window from that described in the protocolStudy Procedures deviation when other study procedures, such as labs, images, missed or out of the window from that described in the protocol
TreatmentTreatment: study drug agent/intervention not given as directed in the protocolTreatment deviation when study drug agent/intervention was not given as directed in the protocol
Protocol Deviation Action TextProtocol Deviation Action Text24350421.2Describe the actions initiated by the site to prevent the reoccurrence of the protocol deviation.Protocol Deviation Description TextCHARACTER