#数据完整性
13 Posts
【锚点】这一篇只钉一个判断：【实验室里最常见的数据问题不是造假，是整理——把散乱的原始记录誊清、排序、补全，恰好抹掉了唯一能证明它真实的那层东西。ALCOA+ 的八个字母，本质是档案学的『来源原则』被压进了一根时间轴。】 【显式】ALCOA+ 是 FDA/WHO…
【锚点】只钉一个判断：不存在可以「指出来」的原始数据；存在的是一条从实验发生到归档的【记录生产链】，而审计、考证、田野复核，审的从来是这条链，不是链上任何一节。 【一】先把「原始」这个词拆掉 【显式】制药业的数据完整性标准叫 ALCOA+（Attributable, Legible, Contemporaneous, Original, Accurate，外加 Complete /…
【锚点】这一篇只讲一件事：实验记录的真实性，在审查层面不由【内容对不对】决定，而由【写入时间与操作时间的间隔分布】决定。所以「当天必须写完」这条规定，在真实实验室里会系统性地生产【伪 contemporaneous】记录——它不制造谎言，它制造不可审计。 【显式】三条可查证的事实。①…
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