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AI工具实战应用创新大赛·一等奖 | 周俊杰:AI辅助受试者入排标准核对实践

AI工具实战应用创新大赛·一等奖 | 周俊杰:AI辅助受试者入排标准核对实践

AI工具实战

应用创新大赛

AI提效智多星 —— 

聚焦实战,分享赋能

杰诺医学于2026年6月成功举办首届“AI提效智多星”AI工具实战应用创新大赛。本次大赛旨在鼓励大家将AI工具融入真实业务场景,提升工作效率与创新能力。参赛选手围绕AI在临床试验、项目管理、日常办公等场景中的实际应用,带来了精彩纷呈的案例展示。

一等奖

AI辅助受试者入排标准核对实践

经过激烈角逐与评委评审,来自项目管理四部的周俊杰凭借作品《AI辅助受试者入排标准核对实践》脱颖而出,荣获一等奖。

01

痛点洞察

在医疗器械临床试验中,受试者入排标准核对是决定项目质量的关键一环——它直接关系到入组质量、方案依从性、GCP合规性、数据完整性和项目进度。

但这又是一项典型的"高频、重复、规则明确"的工作。一份方案动辄数十页,入选与排除标准涉及医学指标、病史、合并用药、检查时间窗等多个维度,彼此交错。项目团队每例候选受试者都要反复翻阅方案逐条比对,单例常需 20–30分钟;个别排除条件或时间窗限制容易被忽略,复盘时才发现;而 CRA、CRC、PM 与研究者之间,对同一条款的理解也可能存在偏差。

周俊杰敏锐地捕捉到这一痛点,并尝试用 AI 工具给出解决方案。

02

作品亮点

他没有把 AI 当作"问答机器",而是把它当成搭建工具的助手。

作为非程序员,他通过自然语言描述需求,借助 Claude Opus 与 VS Code,将方案中的入排标准逐条拆解为可回答的"是否…"核对问题,并为每条设定判断规则,最终生成了一个轻量化的网页核对工具。工具支持三态判断(符合 / 不符合 /待确认),能将不符合与待确认的条目实时归类、自动汇总,并一键输出核对摘要。

更重要的是,他在工具中固化了清晰的合规边界:先脱敏再使用、AI 输出必须人工复核、医学判断与最终入组由研究者确认。AI始终定位为"筛选辅助工具",而非医学决策系统。

03

核心成果

  • 单例受试者入排核对效率提升约 60%(从20–30分钟降至5–10分钟),查找方案标准的时间也从10–15分钟缩短到1–2分钟

  • 不符合与待确认条目自动归类,核对更完整,减少人工遗漏

  • 输出标准化核对摘要,PM、CRC 与研究者之间的沟通从"口头描述"变为"摘要交接",口径更统一

  • 整套方法论可复制——遵循"选痛点 → 结构化规则 → 写清晰 Prompt → 生成校对 →真实场景验证"的五步法,可推广到访视窗口核对、EDC 逻辑核查、方案偏离识别、伦理资料核对等多种项目管理场景

04

价值展望

这个案例的意义,不只在于一个工具或一次提效,而在于它提供了一种可复用的思路:把写在方案里的规则,转化为可以按步骤执行的核对流程。

AI 不是替代临床试验专业人员,而是帮助我们把专业经验固化成流程工具,让项目管理更高效、更清晰,也更可追踪。

END

杰诺医学

一家专业的医疗器械临床试验CRO公司

基本 文件 流程 错误 SQL 调试
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  1. CONNECT:[ UseTime:0.001103s ] mysql:host=127.0.0.1;port=3306;dbname=wenku;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.001720s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.000817s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.000667s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.001417s ]
  6. SELECT * FROM `set` [ RunTime:0.000609s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.001665s ]
  8. SELECT * FROM `article` WHERE `id` = 745188 LIMIT 1 [ RunTime:0.003980s ]
  9. UPDATE `article` SET `lasttime` = 1781258798 WHERE `id` = 745188 [ RunTime:0.003350s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 64 LIMIT 1 [ RunTime:0.000264s ]
  11. SELECT * FROM `article` WHERE `id` < 745188 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.000470s ]
  12. SELECT * FROM `article` WHERE `id` > 745188 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.000486s ]
  13. SELECT * FROM `article` WHERE `id` < 745188 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.001590s ]
  14. SELECT * FROM `article` WHERE `id` < 745188 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.000828s ]
  15. SELECT * FROM `article` WHERE `id` < 745188 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.003364s ]
0.112467s