新药临床试验期间药物警戒和风险控制研究二:临床试验方案、研究者手册和知情同意书监管要求研究
智会静, 詹骁靖, 李浩, 左晓春, 邵颖, 吕心欢, 周凌芸
Research II on Pharmacovigilance and Risk Control During Clinical Trials of New Drugs: A Study on Regulatory Requirements of Pharmacovigilance for Clinical Trial Protocols, Investigator's Brochure and Informed Consent Forms
Zhi Huijing, Zhan Xiaojing, Li Hao, Zuo Xiaochun, Shao Ying, Lü Xinhuan, Zhou Lingyun
中国药事
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2022, (6): 624
-629
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DOI: 10.16153/j.1002-7777.2022.06.004
