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CLINICAL-TRIALS-BASICS5 MIN READ

Use SBAR for an AE escalation

Structure a safety escalation to the PI using Situation, Background, Assessment, and Recommendation.

Dr. Shah DS Principal Investigator S Situation B Background R Recommendation Safety handoff 20 sec The moment A participant reports a new widespread rash after dose 2. The PI has one minute before the next patient. The handoff must be short enough to hear and complete enough to act. Dose 2 temporal link PI severity and causality owner

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