AE relationship to study product

The possible relationship of an adverse event to use of study product is assessed by the investigator. The terminology for these assessments can vary from one reporting system to the next. The DMID (S)AE reporting system uses the following terms to describe the relationship of an AE to the study product:

  • Definitely: Clear-cut temporal association and no other possible cause.
  • Probably: Clear-cut temporal association, and a potential alternative etiology is not apparent.
  • Possibly: Less clear temporal association; other etiologies also possible. Temporal association between the AE and the study product and the nature of the event is such that the study product is not likely to have had any reasonable association with the observed illness/event (cause-and-effect relationship improbable but not impossible).
  • None: The AE is completely independent of study product administration; and/or evidence exists that the event is definitely related to another etiology.

Note: Not all study sponsors use the same SAE terminology when determining severity and relationship. In your studies, you MUST use the system provided by the respective sponsor.

Source: National Institute of Allergy and Infectious Diseases. International Centers For Tropical Disease Research Network (ICTDR) Investigator Manual: Monitoring And Reporting Adverse Events, Bethesda, MD; 2003.