id: ADSL
label: Subject-Level Analysis Dataset
class: SUBJECT LEVEL ANALYSIS DATASET
structure: One record per subject
keys: USUBJID

population:
  base:
    - domain: DM
      depends:
        - USUBJID
      filter: USUBJID != ""
  global:
    - filter: RANDFL == "Y"
      depends:
        - RANDFL

columns:
  - id: STUDYID
    label: Study Identifier
    method: DM.STUDYID
    core: Req

  - id: USUBJID
    label: Unique Subject Identifier
    method: DM.USUBJID
    core: Req

  - id: SUBJID
    label: Subject Identifier for the Study
    method: DM.SUBJID
    core: Req

  - id: SITEID
    label: Study Site Identifier
    method: DM.SITEID
    core: Req

  - id: AGE
    label: Age
    method: DM.AGE
    core: Req

  - id: AGEU
    label: Age Units
    method: DM.AGEU
    core: Req

  - id: SEX
    label: Sex
    method: DM.SEX
    core: Req

  - id: RACE
    label: Race
    method: DM.RACE
    core: Req

  - id: TRT01P
    label: Planned Treatment for Period 01
    method: DM.ARM
    core: Req

  - id: TRT01A
    label: Actual Treatment for Period 01
    method: DM.ACTARM
    core: Req

  - id: SAFFL
    label: Safety Population Flag
    method: Derived based on treatment exposure
    core: Req

  - id: RANDFL
    label: Randomized Population Flag
    method: Set to "Y" if subject was randomized
    core: Req
