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Long NameScreening NCI Standard Template
DefinitionThe collection of CDEs used in the screening module. In most cases, patient data is not collected on a clinical trial unless the patient passes the eligibility screening. However, on some studies, it is important to collect information about screen failures as this may help in evaluating the screening criteria itself. This information can then be used to identify issues with overly restrictive eligibility criteria that may lead to low accrual, or may identify new opportunity for clinical trials. This Screening CRF module provides the ability to capture the reasons for screen failures.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowDRAFT NEW
TypeCRF
Public ID2960861
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 Screening QuestionThis item must be included when this data is collected for reporting.
Does the participant meet all screening criteria?Clinical Trial Screening Indicator29606751.0CHARACTER
NoNoThe non-affirmative response to a question.
YesYesThe affirmative response to a question or activity.
Optional Screening QuestionsThere is no requirement for inclusion of these elements on the case report form. If the design and scientific questions posed in the study dictate the need to collect this type of data, these elements should be included.
If not, which screening criteria not met?Clinical Trial Screening Ineligibility Reason Text29608601.0CHARACTER
Checklist Version DateEligibility Determination Checklist Version Date29606831.0DATE
Screen Completion DateScreen Date21846911.0DATEDD/MON/YYYY