The Clinical Trial SAE

Process a Serious Adverse Event from a clinical trial setting

Role: Drug Safety Scientist (Sponsor)

Context: You're working on a Phase III randomized, double-blind, placebo-controlled trial for Neurobalance (treatment for epilepsy). The CRO has just faxed an urgent SAE report from a trial site.

Task: Process this SAE and determine appropriate regulatory actions.

Step 1 of 3

The SAE Report

case

SAE Form received from Site 042 (Dr. Yamamoto, Principal Investigator): Subject: NB-3042-118, 29-year-old male Event: Stevens-Johnson Syndrome (SJS) Onset: Day 14 of treatment Event Description: Subject developed widespread blistering skin lesions, mucosal involvement, and fever (39.2°C). Admitted to burn unit. Currently receiving IV fluids and wound care. Investigator Assessment: Related to study drug Treatment arm: BLINDED Concomitant meds: Levetiracetam 500mg BID (ongoing background therapy) SAE form received by sponsor: Today at 2:30 PM

What is the FIRST critical action you should take?