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The following table lists the non-standard variables used in this document, and gives their parent domain and variable-level metadata.

Parent DomainVariableLabelSAS Data TypeDefine-XML Data TypeCodelist/Controlled TermsRoleDescriptionNotes

FA, LB

--COLSRTCollected Summary Result TypeChartext
Non-Standard Variable Qualifier of --ORRESVariable qualifier of --TESTCD and --TEST. Used to indicate the type of collected summary result (e.g., MAXIMUM, MINIMUM, MEAN, MEDIAN, NADIR). This includes source summary results collected on a CRF or provided by an external vendor (e.g., central lab). If the summary result is derived using individual source data records, this summary result should be represented in ADaM. If a sponsor has both a collected summary result and a derived summary result, the collected summary result should be represented in SDTM and the derived summary result should be represented in ADaM.

FA, LB

--SOURCE NUT-103 - Getting issue details... STATUS Source of DataChartext
Non-Standard Record QualifierThe original source of the data such as RECALL, MEDICAL RECORD, CENTRAL LAB. This should not be confused with EVAL which describes the role of the person who provided the evaluation.
BE--SPECSpecimen TypeChartextSPECTYPENon-Standard Record Qualifier of --TESTCDDefines the type of specimen used for a measurement. Examples: SPUTUM, BLOOD, PUS.
EX--NADEVINumber of Administrations in Eval. Int.Numinteger
Non-Standard Record QualifierThe number of times the treatment was administered within a specific evaluation interval.
(Parenthesis indicates CDISC/NCI codelist)

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