GUIDANCE Rev. 1
Guideline on Strategies to Identify and Mitigate Risks for First-in-Human and Early Clinical Trials
ABSTRACT — EDITORS' SUMMARY
FIH-specific risk identification and mitigation. Critical for sponsor protocol design and oversight of phase 1 unit trials.
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PDF · CANONICAL LINK https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-strategies-identify-mitigate-risks-first-human-early-clinical-trials-investigational_en.pdf ↗ RELATED · SAME AUTHORITY