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Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

CRITy

Analysis Criterion y

Char

Perm

A text string identifying a pre-specified criterion within a parameter, for example SYSBP > 90. Required if CRITyFL is present. In some cases, the presence of the text string indicates that the criterion is satisfied on this record and CRITyFL is set to Y, while a null value indicates that the criterion is not satisfied or is not evaluable and is accompanied by a null value in CRITyFL. In other cases, the text string identifies the criterion being evaluated and is populated on every row for the parameter, but whether or not the criterion is satisfied is indicated by the value of the variable CRITyFL. See CRITyFL and CRITyFN.

Refer to ADD LINK Section 4.7, Identification of Records which Satisfy a Predefined Criterion for Analysis Purposes, for additional discussion of CRITy, CRITyFL and CRITyFN.

CRITyFL

Criterion y Evaluation Result Flag

Char

Y or Y, N

Cond

Character flag variable indicating whether the criterion defined in CRITy was met by the data on the record. See CRITy for more information regarding how to use CRITy and CRITyFL to indicate whether a criterion is met. Required if CRITy is present.

Refer to ADD LINK Section 4.7, Identification of Records which Satisfy a Predefined Criterion for Analysis Purposes, for additional discussion.

CRITyFN

Criterion y Evaluation Result Flag (N)

Num

1 or 1, 0

Perm

Numeric representation of CRITyFL. There must be a one-to-one relationship between CRITyFN and CRITyFL within a parameter.

CRITyFN cannot be present unless CRITyFL is also present. When CRITyFL and CRITyFN are present, then on a given record, either both must be populated or both must be null.

MCRITy

Analysis Multi-Response Criterion y

Char

Perm

A text string identifying a pre-specified criterion within a parameter, where the criterion can have multiple responses (as opposed to CRITy which has binary responses). Required if MCRITyML is present. For example, the grade of a lab analyte is compared to the baseline grade, with the possible conditions being 0 to 1, 0 to 2, etc. The text string identifies the criterion being evaluated (for example, "Grade increase") and is populated on every row for the parameter; which level of the criterion is satisfied is indicated by the value of the variable MCRITyML (for example "0 to 1", "0 to 2", etc.).

See MCRITyML and MCRITyMN below, and refer toADD LINK Section 4.7, Identification of Records which Satisfy a Predefined Criterion for Analysis Purposes for additional discussion of MCRITy, MCRITyML, and

MCRITyMN.

MCRITyML

Multi-Response Criterion y Evaluation

Char

Cond

Character variable indicating which level of the criterion defined in MCRITy was met by the data on the record. See MCRITy for more information regarding how to use MCRITy and MCRITyML to indicate whether a criterion was met. Content is sponsor-defined. Required if MCRITy is present.

MCRITyMN

Multi-Response Criterion y Eval (N)

Num

Perm

Numeric representation of MCRITyML. There must be a one-to-one relationship between MCRITyMN and MCRITyML within a parameter. Content is sponsor-defined.

MCRITyMN cannot be present unless MCRITyML is also present. When MCRITyML and MCRITyMN are present, then on a given record, either both must be populated or both must be null.