临床研究生物样本与风险管控要点速览

“临床试验入组虽结束，质控却无终点”

近日，麦科奥特「CO学习角」开展质控专题培训，主题为 “临床试验质控发现常见问题分享” 。临床QC经理担任讲师，聚焦生物样本全链条管理与风险防控实操，为团队带来一场“接地气、可落地”的实战分享。

分享开篇即点明一个关键认知：质控的“最后防线”往往在入组完成后最容易被忽视。样本处理、数据闭环、文档溯源——越是后期环节，越需要“步步留痕”。

临床试验质量无小事，每一个签字、每一次记录、每一项操作，都是对科学、对受试者、对行业的负责。

质控中需重点关注源文件风险点：采集记录是否完整及时、采血量与时间是否符合方案、离心与静置时限是否合理、设备型号与校准是否一致、储存温度与超温处置是否规范、转运交接与温湿度记录是否闭环。任何时间逻辑矛盾、信息缺失，都可能埋下数据失真隐患。

这些问题看似微小，却直接触碰合规红线：轻则数据无效，重则影响受试者安全、导致核查不通过。风险管控的关键，不在于事后整改，而在于事前预防、事中严控、全程留痕。

分享会的核心结论是：风险管控的关键，不在于事后整改，而在于事前预防、事中严控、全程留痕。陈建茹鼓励团队将质控意识嵌入日常操作，从“被动发现问题”转向“主动识别风险”。现场同事也就实际项目中遇到的样本超温、记录缺失等场景进行了热烈讨论。

本次分享将质控理论转化为可落地的行动清单，帮助项目团队理清了后期质控的关键逻辑。未来，CO学习角将持续聚焦临床实操痛点，以专业推动创新药物研发。

Although enrollment has ended, quality control never stops. On April 17, 2026, the "CO Learning Corner" of Micot launched quality control training, themed "Common Issues Found in Clinical Trial Quality Control ". Clinical QC Manager, served as the lecturer, focusing on the whole-chain management of biological samples and practical risk prevention, delivering a hands-on and actionable session for the team.

The session began by highlighting a key insight: the "last line of defense" in quality control is often most easily overlooked after enrollment ends. Sample processing, data closure, and document traceability—the later the stage, the more critical it is to leave a trace at every step.

Nothing is trivial in clinical trial quality. Every signature, record and operation is a responsibility to science, subjects and the industry.

In quality control, special attention must be paid to risk points in source documents: whether collection records are complete and timely, whether blood collection volume and time comply with the protocol, whether centrifugation and resting time limits are reasonable, whether equipment model and calibration records are consistent, whether storage temperature and overtemperature handling are standardized, and whether transport handover and temperature/humidity records are closed-loop. Any logical contradiction or missing information in timing may bury hidden dangers of data distortion.

These problems seem minor, but directly touch the red line of compliance: mild cases lead to invalid data, severe cases affect subject safety and result in inspection failure. The key to risk control is not post rectification, but prevention beforehand, strict control during the process, and full documentation.

The key takeaway of the session: the essence of risk control is not post-rectification, but prevention beforehand, strict control during the process, and full documentation. Chen encouraged the team to embed quality awareness into daily operations, shifting from "passively finding problems" to "actively identifying risks." Colleagues also engaged in lively discussions on real scenarios such as sample over temperature and missing records.

This session transformed quality control theories into an actionable checklist, helping project teams clarify the key logic of late-stage quality control. In the future, the CO Learning Corner will continue to focus on clinical practical pain points and drive innovative drug development with professionalism.