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Long NameEnrollment NCI Standard Template
DefinitionThe collection of CDEs used in the Enrollment module. The enrollment process occurs when the center's registrar receives and reviews the registration information and makes a determination to accept or not accept the application. If the participant is deemed acceptable, the center enrolls the participant in the study and the coordinating center returns a notification to the registering institution indicating that the proposed participant is enrolled.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowRELEASED
TypeCRF
Public ID2745052
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 Enrollment QuestionsThese items must be included when this data is collected for reporting.
Study Participant IdentifierPatient Identifier20033014.0Enter the identifier assigned to a participant.CHARACTER
Enrollment DateParticipant Enrollment Date27465411.0Enter the date the participant is accepted into the study.DATEMM/DD/YYYY
Conditional Enrollment QuestionsThere are business rules to indicate situations under which these elements should be used on a case report form.
Treatment ArmProtocol Arm Assignment Text24545281.0Enter the term that describes the assigned treatment arm. Conditionality Rule: Element is required by sponsor. CHARACTER
Intergroup Participant IdentifierPatient Multiple Clinical Trials Cooperative Group Identifier Number24653081.0Enter the identifier assigned to an intergroup clinical protocol participant. Conditionality Rule: Element is required by sponsor. CHARACTER
Optional Enrollment 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.
Site RegistrarProtocol Registrar Name21723.0CHARACTER