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Long NameHeader NCI Standard Template
DefinitionThe collection of CDEs used in the header module.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowRELEASED
TypeCRF
Public ID2960795
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 Header QuestionsThese items must be included when this data is collected for reporting.
CRF NameCase Report Form Name30090341.0Enter the name of the case report form.CHARACTER
Study IdentifierProtocol Clinical Study Identifier Number27464591.0Enter the numeric or alphanumeric identification assigned to the study.CHARACTER
Study Participant IdentifierPatient Identifier20033014.0CHARACTER
Conditional Header QuestionsThere are business rules to indicate situations under which this element should be used on a case report form.
Registering Institution CodeRegistering Institution Identification Code20033074.0Conditionality Rule: If the Sponsoring organization requests this information for Regulatory reporting, then it MUST be included on the case report form.CHARACTER
Optional Header 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.
Participant InitialsPatient Initials Name20010394.0Enter the initial letters of the first, middle, and last names.CHARACTER
Participant Local IdentifierHealthcare Facility Participant Identifier27464681.0Enter the unique numeric or alphanumeric designation assigned by a healthcare facility used to link to the participant's medical record.ALPHANUMERIC
Current Cycle NumberTreatment Current Course Number20724.1Enter the Numeric value assigned to identify a period of protocol activity; a course is comprised of multiple cycles of protocol-dictated activities.NUMBER
Treating InstitutionTreating Institution Identifier Code24815331.0Enter the code that unqiuely identifies all the organizations providing treatment for a participant.CHARACTER
Intergroup Participant IdentifierPatient Multiple Clinical Trials Cooperative Group Identifier Number24653081.0Enter the numeric sequent used to uniquely identify an individual participating in an intergroup clinical protocol. CHARACTER
Reporting Period Start DateTreatment Reporting Period Begin Date29934.0Enter the start date of the reporting period:DATEmm/dd/yyyy
Reporting Period End DateTreatment Reporting Period End Date29924.0Enter the end date of the reporting period:DATEmm/dd/yyyy