Versions Compared

Key

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

...

Other domains have been established to record other types of interventions. Interventions administered to the subject coincident with the study assessment period are referred to as concomitant medications and represented in the Concomitant/Prior Medications (CM) domain and interventions administered as protocol-specified study products are represented in the Exposure (EX) and Exposure as Collected (EC) domains.

In clinical trials studying tobacco products, tobacco products being used for non-medical purpose will be represented in the SU domain. However, products being used to reduce the usage of these self-administered tobacco products, will be considered either concomitant medications, or the product under study.  

...