CAJ | 학술논문

介绍制药业统计学家协会标准操作规程指南的第5～8部分。强调必须仔细设计随机化编码表的产生、分发和破盲的程序，同时应核查是否已遵循了所制定的随机化。数据管理要有详细计划，特别是数据库设计、管理和维护的程序和责任人。期中分析必须事先计划，要尽可能避免期中分析对试验的影响。最后讨论了统计报告的撰写和应包含的内容。
개소제약업통계학가협회표준조작규정지남적제5～8부분。강조필수자세설계수궤화편마표적산생、분발화파맹적정서，동시응핵사시부이준순료소제정적수궤화。수거관리요유상세계화，특별시수거고설계、관리화유호적정서화책임인。기중분석필수사선계화，요진가능피면기중분석대시험적영향。최후토론료통계보고적찬사화응포함적내용。
Part 5～8 of Guidelines for standard operating procedures produced by the Statisticians in the Pharmaceutical Industry (PSI) are introduced. Thoughtful procedures for designing, distributing and breaking randomized code lists are emphasized as well as supervising the actualization of the randomization procedure worked out. There should be detailed data management plan indicating the procedure of and the one responsible for the design and maintenance of the database. Interim analysis must be aforethought and consideration should be given to avoid its possible biased impact on the running trial. The writing and contents of statistical reports are also discussed.