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Outstanding Issues 

  • The standard SDTM uses the term study treatment for several variables ( AEREL, AEACN. Should this be changes to study product (or another term).  
  • Needs correct reference   More information can be found in  SDTMIG Section 4.4.7, Use of Relative Timing Variables. 

The Adverse Events (AE) domain is based on the Events General Observation class. The AE domain is used to represent clinical data describing "any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment" (ICH E2A). In consultation with regulatory authorities, sponsors may extend or limit the scope of adverse event collection (e.g., collecting pre-treatment events related to trial conduct, not collecting events that are assessed as efficacy endpoints). Events included in the AE domain should be consistent with protocol requirements. Adverse event terms may be captured either as free text or via a prespecified list of terms.

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