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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:
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.