These flags identify whether the subject is included in the specified population. A minimum of 1 subject-level population flag variable is required in ADSL.

Not all of the indicators listed here need to be included in ADSL. As stated in Section 2.9.3.4, Flag Variable Conventions, only those indicators corresponding to populations defined in the statistical analysis plan or populations used as a basis for analysis need be included in ADSL.

This list of flags is not meant to be all-inclusive. Additional population flags may be added.

The values of subject-level population flags cannot be blank. If a flag is used, the corresponding numeric version (*FN, where 0 = No and 1 = Yes) of the population flag can also be included. Please also refer to Section 2.9.3.4, Flag Variable Conventions.

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

FASFLFull Analysis Set Population FlagCharY, NCond

Must be included if FASFL is defined and required per the SAP

SAFFL

Safety Population Flag

Char

Y, N

Cond

Must be included if SAFFL is defined and required per the SAP

PPROTFL

Per-Protocol Population Flag

Char

Y, N

Cond

Must be included if PPROTFL is defined and required per the SAP

COMPLFL

Completers Population Flag

Char

Y, N

Cond

Must be included if COMPLFL is defined and required per the SAP

RANDFL

Randomized Population Flag

Char

Y, N

Cond

Must be included if RANDFL is defined and required per the SAP

ENRLFL

Enrolled Population Flag

Char

Y, N

Cond

Must be iif ENRLFL is defined and required per the SAP

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