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Long NameEligibility NCI Standard Template
DefinitionThe collection of CDEs used in the eligibility module. The purpose of the Eligibility CRF module is to establish the outcome of each patient consented and/or screened for the trial, as appropriate.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowDRAFT NEW
TypeCRF
Public ID2960932
Version1.0
Module Long NameModule InstructionsQuestionCDECDE Public IDCDE VersionQuestion InstructionsValue Domain Data TypeValue Domain Unit of MeasureDisplay FormatValid ValueForm Value Meaning TextForm Value Meaning Desc.
Mandatory Eligibility QuestionThis item must be included when this data is collected for reporting.
Is the participant eligible for inclusion on this studyPatient Eligibility Indicator12354.0CHARACTER
NoNoNo value exists.
YesYesNo value exists.
Conditional Eligibility QuestionsThere are business rules to indicate situations under which these elements should be used on a case report form.
Was a waiver granted?Waiver Indicator20038553.0This question is not permitted on NCI trials and is, therefore, conditional upon the sponsor permitting waivers.CHARACTER
N/ANot ApplicableDetermination of a value is not relevant in the current context.
NoNoNo value exists.
YesYesNo value exists.
Reason for waiverEligibility Waiver Reason Text29608751.0This question is conditional upon the sponsor permitting waivers.CHARACTER
Waiver #Waiver Number20033893.0ALPHANUMERIC
Reason patient not eligiblePatient Ineligibility Reason29608901.0This question is conditional because some trials that do not require specific consent will not capture information on patients not deemed eligible.CHARACTER
Did not meet Eligibility CriteriaIneligibilityThe state or quality of being disqualified by law, rule, or provision.
Insurance/financial issuesInsurance And/Or Financial ProblemA mechanism for guarding against financial aspects of risk by making payments in the form of premiums to an insurance company, which pays an agreed-upon sum to the insured in the event of loss.: Used to indicate that either or both of two items or options: Concerning or related to monetary conditions.: Problem; a state of difficulty that needs to be resolved.
Investigator DecisionInvestigator DecisionAn individual who conducts scientific research. In a clinical setting this individual actually conducts or/and supervises the clinical investigation and study-related procedures; monitors the safety of the trial subjects and investigational staff (i.e., under whose immediate direction an agent is administered or dispensed to a subject), collects and analyses data and study documents, and provides reports in compliance with applicable requirements.: A position, opinion, or judgment reached on an issue under consideration.
Logistical and/or transportation issuesLogistical and/or transportation issuesLogistical and/or transportation issues
Other health issuesOther Health ProblemDifferent than the one(s) previously specified or mentioned.: The state of the organism when it functions optimally without evidence of disease.: Problem; a state of difficulty that needs to be resolved.
Other, specifyOther SpecifyDifferent than the one(s) previously specified or mentioned.: Specify; be specific about something; define clearly.
Participant DecisionParticipant DecisionSomeone who takes part in an activity.: A position, opinion, or judgment reached on an issue under consideration.
Prior problems with protocol compliancePrior Protocol Compliance ProblemEarlier in time or order.: A protocol is a rule which guides how an activity should be performed; a set of formal rules used to specify the format of an exchange of data.: Voluntary cooperation of the patient in following a prescribed regimen.: Problem; a state of difficulty that needs to be resolved.
Specify reason not eligiblePatient Ineligibility Other Specify Text29608921.0CHARACTER
Optional Eligibility QuestionThere is no requirement for inclusion of this element on the case report form. If the design and scientific questions posed in the study dictate the need to collect this type of data, this element should be used.
Checklist Version DateEligibility Determination Checklist Version Date29606831.0DATE
Eligibility Determined DateEligibility Determination Date29608791.0DATEDD/MON/YYYY