RACD Compliance with FDA Safety Reporting ... - SIGs

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<strong>Safety</strong> Office Review Functions • Investigator brochures amendments • Package inserts changes • <strong>FDA</strong> IND annual reports • Final study reports • Monitoring visit reports • Case report forms 42
Training • Guides • UP Guide • TORO/SRCP Q&A • DSMB Data Tables guidance • Presentations – 33 conducted • Computer based training • DSMB on-line training modules 43
Page 1 and 2: Compliance with FDA Safety Reportin
Page 3 and 4: 1. Safety Reporting Requirements 3
Page 6: International Conference on Harmoni
Page 9: FDA • Studies conducted Title 21
Page 12: NIH Institute & Center (IC) • Off
Page 15 and 16: NIAID 15
Page 17 and 18: Regulatory Compliance and Human Sub
Page 19 and 20: Diseases • Infectious Diseases
Page 21 and 22: NIAID Active Protocols FY2012 Proto
Page 23 and 24: 4. Safety Office Services and Initi
Page 25 and 26: Changes to the NIAID Protocol Templ
Page 28 and 29: IRB Stipulations Review Project •
Page 30 and 31: Safety Review and Communications Pl
Page 32 and 33: SRCP Verification Form 32
Page 34 and 35: Safety Office Role Pre Sept. 2011 P
Page 36 and 37: Safety Oversight Committees • Dat
Page 40 and 41: Expedited Safety Reporting • Inve
Page 44 and 45: DSMB Training URL: https://dsmblear
Page 46 and 47: SUMMARY (con’t) • Management of
Page 48: Acknowledgements • H. Clifford La

RACD Compliance with FDA Safety Reporting ... - SIGs

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