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.