撰写医疗器械临床试验方案需要包含哪些内容？

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　　众所周知，通过临床试验获得有效数据是评价医疗器械是否安全有效的重要方式之一。根据医疗器械注册管理办法中的相关规定，未列入免于进行临床试验目录的第二类、第三类医疗器械产品申请注册，应当进行临床试验。食品药品监督管理总局指出，未在境内外批准上市的新产品，安全性以及性能尚未经医学证实的，临床试验方案设计时应当先进行小样本可行性试验，待初步确认其安全性后，再根据统计学要求确定样本量开展后续临床试验。

　　因此，在开展医疗器械临床试验前，申办者需要按照试验用医疗器械的类别、风险、预期用途等组织制定科学、合理的临床试验方案。那么，应当如何撰写临床试验方案，需要包含哪些内容呢？

　　在医疗器械临床试验质量管理规范中，规定医疗器械临床试验方案应当包括一般信息、临床试验的背景资料、试验目的、试验设计、安全性评价方法、有效性评价方法、统计学考虑、对临床试验方案修正的规定、对不良事件和器械缺陷报告的规定、直接访问源数据或文件、临床试验涉及的伦理问题和说明以及知情同意书文本、数据处理与记录保存、财务和保险、试验结果发表约定等内容。其中，部分内容可以包括在方案的其他相关文件中(比如研究者手册)；临床试验机构的具体信息、试验结果发表约定、财务和保险可以在试验方案中表述，也可以另行制定协议加以规定。

　　如果多中心临床试验由多位研究者按照同一试验方案在不同的临床试验机构中同期进行，那么这个试验方案的设计和实施应当至少包括以下内容：

　　1.试验方案由申办者组织制定并经各临床试验机构以及研究者共同讨论认定，且明确牵头单位临床试验机构的研究者为协调研究者；

　　2.协调研究者负责临床试验过程中各临床试验机构间的工作协调，在临床试验前期、中期和后期组织研究者会议，并与申办者共同对整个试验的实施负责；

　　3.各临床试验机构原则上应当同期开展和结束临床试验；

　　4.各临床试验机构试验样本量以及分配、符合统计分析要求的理由；

　　5.申办者和临床试验机构对试验培训的计划与培训记录要求；

　　6.建立试验数据传递、管理、核查与查询程序，尤其明确要求各临床试验机构试验数据有关资料应当由牵头单位集中管理与分析；

　　7.多中心临床试验结束后，各临床试验机构研究者应当分别出具临床试验小结，连同病历报告表按规定经审核后交由协调研究者汇总完成总结报告。

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