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Variable Name
Variable Label
Type
Codelist/ Controlled Terms
Core
CDISC Notes
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
Must be included if PPROTFL is defined and required per the SAP
COMPLFL
Completers Population Flag
Must be included if COMPLFL is defined and required per the SAP
RANDFL
Randomized Population Flag
Must be included if RANDFL is defined and required per the SAP
ENRLFL
Enrolled Population Flag
Must be iif ENRLFL is defined and required per the SAP