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Investigators’ Experience With Expedited Safety Reports Prior to the FDA’s Final IND Safety Reporting Rule

机译：调查人员在FDA最终安全报告规则之前加快安全报告的经验

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Judith M. Kramer; David Vock; Howard E. Greenberg; Cheri Janning; Lynda Szczech; Miklos Salgo; Suzanne Gagnon; Susan Ellenberg;
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1. Investigators' Experience With Expedited Safety Reports Prior to the FDA's Final IND Safety Reporting Rule [J] . Judith M. Kramer, David Vock, Howard E. Greenberg Drug information journal . 2014,第4期

机译：研究人员在FDA最终IND安全报告规则之前对快速安全报告的经验
2. Investigators' Experience With Expedited Safety Reports Prior to the FDA's Final IND Safety Reporting Rule [J] . Kramer Judith M., Vock David, Greenberg Howard E., Therapeutic innovation & regulatory science. . 2014,第4期

机译：研究人员在FDA最终IND安全报告规则之前对快速安全报告的经验
3. REGULATORY WATCH Evaluating the potential for digital submission of expedited premarket safety reports to the FDA [J] . Khozin Sean, Chuk Meredith, Kim Tamy, Nature reviews Drug discovery . 2016,第10期

机译：监管手表评估向FDA提交快速的上市前安全报告数字提交的可能性
4. LEGAL AND TECHNICAL IMPLICATIONS OF THE SAFETY RECOMMENDATIONS ISSUED IN THE FINAL REPORTS OF THE CIVIL AIR ACCIDENTS AND INCIDENTS INVESTIGATIONS [C] . Cuerno C., Guerrero M.J., Arnaldo R., Congress of the International Council of the Aeronautical Sciences . 2012

机译：对民用航空事故和事故征候调查的最终报告中提出的安全建议的法律和技术含义
5. Patient Safety Problems, Procedures, and Systems Associated with Safety Reporting and Turnover [D] . Hilario, Grace. 2019

机译：与安全报告和营业额相关的患者安全问题，程序和系统
6. Investigators’ Experience With Expedited Safety Reports Prior to the FDA’s Final IND Safety Reporting Rule [O] . Judith M. Kramer, David Vock, Howard E. Greenberg, -1

机译：FDA最终IND安全报告规则之前研究人员在快速安全报告方面的经验
7. The FDA's Final Rule on Expedited Safety Reporting: Statistical Considerations [O] . Janet Wittes, Brenda Crowe, Christy Chuang-Stein, 2015

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Investigators’ Experience With Expedited Safety Reports Prior to the FDA’s Final IND Safety Reporting Rule

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