Reporting concepts

ICMS reporting guidance distinguishes adverse events, serious adverse events, and unanticipated adverse events, including intensity and relationship to treatment.

  • Adverse event: an unfavorable medical occurrence after participation or treatment.
  • Serious adverse event: an event involving outcomes such as death, life-threatening risk, hospitalization, disability, or other medically significant harm.
  • Unanticipated adverse event: an event that is unexpected in nature, severity, or frequency.
  • Intensity can be described as mild, moderate, or severe.
  • Relationship to treatment can be unlikely, possible, or probable.

Process

Serious adverse events and unexpected adverse events should be documented for all study protocols. Serious adverse events, including death from any cause, must be documented whether or not the event appears associated with study treatment.

A completed serious/unexpected/adverse event report form or sponsor report form should be submitted with applicable supporting documentation and the current number of events relative to the current number of study subjects.

  • Report SAE/UAE documentation to the IRB for review.
  • Include applicable supporting documentation.
  • Include current event counts relative to enrolled study subjects.
  • Reports should be received within 10 days of receipt in the investigator's office.
  • Include an acknowledgement field on the cover letter so receipt can be confirmed.