You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 3 Current »

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

STRATAR

Strata Used for Randomization

Char


Perm

STRATAR contains the combination of values of the individual stratification factors used for randomization. The exact format should be determined by the sponsor.

This variable is intended for studies that use stratified randomization.

For example, ">=50, Product experienced, N"

STRATARN

Strata Used for Randomization (N)

Num


Perm

Numeric representation of STRATAR. For example, STRATARN=3 when STRATAR=">=50, Product experienced, N". There must be a one-to-one relationship between STRATARN and STRATAR within a study.

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

STRATwD

Description of Stratification Factor w

Char


Perm

STRATwD is a full text description of the stratification factor "w". This text description will remain constant for all subjects. These descriptive variables are included to quickly and clearly communicate critical study design information as well as to facilitate integration.

For example, STRAT3D="Hypertension"

STRATwR

Strat Factor w Value Used for Rand

Char


Perm

STRATwR is the subject-level value of the "w'th" stratification factor used for randomization.

For example, STRAT3R="N"

STRATwRN

Strat Factor w Value Used for Rand (N)

Num


Perm

Numeric representation of STRATwR. For example, STRAT3RN=0 when STRAT3R="N". There must be a one-to-one relationship between STRATwRN and STRATwR within a study.

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

STRATAV

Strata from Verification Source

Char


Perm

STRATAV contains the entire string value represents the combination of values of the individual stratification factors that should have been used and represents the "as verified" value. The STRATAV variables are based on the source documentation and are determined after randomization. If the values used for the randomization of a given subject were all correct, then STRATAV will equal STRATAR. Otherwise, one or more components of the text string for STRATAR and STRATAV will be different.

The exact format should be determined by the sponsor.

For example, ">=50, Product experienced, Y"

STRATAVN

Strata from Verification Source (N)

Num


Perm

Numeric representation of STRATAV. For example, STRATAVN=4 when STRATVR=">=50, Product experienced, Y". There must be a one-to-one relationship between STRATAVN and STRATAV within a study.

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

STRATwV

Strat Factor w Value from Verif Source

Char


Perm

STRATwV is the "as verified" subject-level value of the "w'th" stratification factor. If the value based on randomization was correct, then STRATwV will equal STRATwR.

For example, STRAT3V="Y"

STRATwVN

Strat Fact w Val from Verif  Source (N)

Num


Perm

Numeric representation of STRATwV. For example, STRAT3VN=1 when STRAT3V="Y". There must be a one-to-one relationship between STRATwVN and STRATwV within a study.

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


  • No labels