Variable Name,Variable Label,Type,"Codelist/ Controlled
Terms",Core,CDISC Notes
ITTRFL,"Intent-To-Treat
Record-Level Flag",Char,Y,Perm,"These indicators identify whether or not the subject was in the specified analysis for the specific record. Useful when the subject is included in the subject-level population, but there are records for the subject that do not satisfy requirements for the population. The valid values of these record- level population indicators are Y or Null. If a flag is used, the corresponding numeric version (*FN, where 1=yes) of the flag can also be included. As described in Section 3.1.1 Item 8, the *FN version of the variable can be included only if the corresponding *FL is also included. Additional indicators may also be used; refer to Section 3.1.4."
SAFRFL,Safety Analysis Record-Level Flag,Char,Y,Perm,
FASRFL,"Full Analysis Set
Record-Level Flag",Char,Y,Perm,
PPROTRFL,"Per-Protocol
Record-Level Flag",Char,Y,Perm,
COMPLRFL,Completers Record- Level Flag,Char,Y,Perm,
ITTPFL,Intent-To-Treat Parameter-Level Flag,Char,Y,Perm,"These indicators identify whether or not the subject was in the specified analysis for the specific parameter. Useful when the subject is included in the subject-level population, but there are parameters for which the subject does not satisfy requirements for the population. The valid values of these parameter-level population indicators are Y or Null. If a flag is used, the corresponding numeric version (*FN, where 1=yes) of the flag can also be included. As described in Section 3.1.1 Item 8, the *FN version of the variable can be included only if the corresponding *FL is also included. Additional indicators may also be used; refer to Section 3.1.4, “Flag Variable Conventions.”"
SAFPFL,"Safety Analysis
Parameter-Level Flag",Char,Y,Perm,
FASPFL,"Full Analysis Set
Parameter-Level Flag",Char,Y,Perm,
PPROTPFL,"Per-Protocol Parameter-Level
Flag",Char,Y,Perm,
COMPLPFL,"Completers Parameter-Level
Flag",Char,Y,Perm,
