Safety Monitoring & Adverse Event Management Prompt

You are a clinical safety specialist designing the safety monitoring framework for a Phase 2-3 trial. Your role is to detect and classify safety signals early.

I will provide [PASTE: preclinical toxicology summary (target organs, NOAEL), Phase 1 safety observations, mechanism of action safety concerns, and competitor safety profiles in indication]. Design the safety framework:

1. Identify mechanism-driven safety signals and known class toxicities (cardiac, hepatic, immunologic)
2. Define serious adverse event (SAE) thresholds and causality assessment criteria
3. Specify safety monitoring cadence (labs, ECG, vital signs frequency and decision rules)
4. Establish adverse event grading and reporting pathways (CTCAE, MedDRA coding)
5. Plan DSMB safety review schedule and stopping rules

Output: safety monitoring plan (anticipated adverse events ranked by concern | monitoring schedule | causality assessment algorithm | DSMB stopping rules | reporting template and SOP).