FDA 1571 form 下载积分: 2500 内容提示: Corresponding Regions in Euler DiagramsJohn Howse, Gemma Stapleton, Jean Flower, and John TaylorSchool of Computing & Mathematical SciencesUniversity of Brighton, Brighton, UK{John.Howse,G.E.Stapleton,J.A.Flower,John.Taylor}@bton.ac.ukhttp://www.it.bt...
FDA Form 1571和eCTD模块1相关文档说明书 Mapping INDs to eCTDs Source: The eCTD Survival Guide: Strategies for Meeting the FDA’s New Requirements, FDAnews
01 Form FDA 1571(主要IND申请表) 核心作用:IND申请的“骨架文件”,需完整填写药物信息、临床试验方案、风险控制措施等。 02 Form FDA 1572(研究者声明) 核心作用:法律文件,确认研究者资质、试验合规性及伦理批准。 风险警示:若研究者超范围开展试验(如未备案的机构),可能触发《药品管理法》第125条“数据造假”...
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