Versions Compared

Old Version 16

changes.mady.by.user Kathleen Mellars

Saved on

compared with

New Version 17

changes.mady.by.user Kathleen Mellars

Saved on

Key

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

TO BE REMOVED ; ISSUES TO BE DISCUSSED  

1: Should  we use SC for all details question about usage and quitting. or FASU....    (e.g.  longest period of abstinence in the past year, Have you attempted to quit smoking, Number of previous attempts to quit smoking, Used patches) , Years of regular smokeless tobacco. (A type of tobacco that is not smoked or burned.) It may be used as chewing tobacco or moist snuff, or inhaled through the nose as dry snuff.)     

2. 4, Is DOSFRM used to identify  Chewing tobacco, snuff, etc. Is this then nicotine as the TRT and the route is ORAL  SNUFF is inhalation.  



The Interventions domains in SDTM capture investigational, therapeutic, and other treatments that are administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., exposure to study product  coincident with the study assessment period (e.g., concomitant medications), or self‑administered by the subject (e.g., use of alcohol, tobacco, or caffeine).

...