RACD Compliance with FDA Safety Reporting ... - SIGs

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<strong>Safety</strong> <strong>Reporting</strong> Requirements 4
Page 1 and 2: Compliance with FDA Safety Reportin
Page 3: 1. Safety Reporting Requirements 3
Page 8 and 9: Department of Health & Human Servic
Page 11 and 12: Office of Human Research Protection
Page 14 and 15: 2. NIAID Intramural Safety Office 1
Page 16 and 17: Division of Clinical Research 16
Page 18 and 19: 3. NIAID Intramural Portfolio 18
Page 20 and 21: Products • Biologics • Vaccines
Page 22 and 23: Regulatory Branch Sponsored Researc
Page 24 and 25: Document Review for Safety Complian
Page 26: Standardized Protocol Safety Sectio
Page 29 and 30: Summary of 21 CFR 312.32 Changes
Page 31 and 32: Safety Review and Communications Pl
Page 33 and 34: SRCP-TORO Assessment of Risk Plan (
Page 35 and 36: Safety Office Role Post Sept 2011 P
Page 37: Standardized Data Tables • CRIMSO
Page 41 and 42: SAE/UP Report Form 41
Page 43 and 44: Training • Guides • UP Guide
Page 45 and 46: SUMMARY • Standardized protocol s
Page 47 and 48: Clinical Safety Office Contact Info

RACD Compliance with FDA Safety Reporting ... - SIGs

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