Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

All clincal studies, including studies on tobacco products, collect general information about a subject/participant. This section shows information typically collected in all clincial studies. For example, study disposition, demographic and subject characteristic information ( e.g., Sex, Age), information about prior tobacco product usage, safety laboratory tests and medical history. Most subject-level observations collected during the study should be represented according to 1 of the 3 SDTM general observation classes: Interventions, Events, or Findings.

Scroll Ignore
Xchild toc
prefix3.4.1

Children Display
alltrue

Pagenav