中国临床药学杂志

目的 探讨数字化技术在临床研究标准操作规程管理中的实践与应用成效。方法 采用自身对照试验，选取某三级甲等医院参与临床试验的40名研究者为研究对象。2024年10月至2025年3月采用传统标准操作规程管理（实施前组），2025年4月至12月应用数字化技术管理标准操作规程（实施后组）。对比分析2组研究者考核成绩、自主学习能力、满意度、职业倦怠水平。结果 实施后组研究者的理论考核成绩[（90.26±2.83）分vs(84.57±2.68)分，P<0.05]、操作考核成绩[（91.36±2.73）分vs(86.49±3.24)分，P<0.05]和自主学习能力评价得分[（161.22±13.94）分vs(136.41±14.72)分，P<0.01]均较实施前组提高。实施后组研究者对标准操作规程体系架构满意度、质控措施接受度及实际应用效果满意度均高于实施前组，差异有统计学意义（P<0.05），且职业倦怠评分[（33.92±7.41）分vs(42.12±8.05)分，P<0.01]较实施前组降低。结论 从全生命周期管理视角出发，以数字化技术赋能临床研究标准操作规程，实现从烦琐约束到效率抓手的转变，充分激发研究者学习主观能动性，缓解职业倦怠，为临床研究中心的高质量建设提供借鉴经验。

AIM To explore the practical paths and application effects of digital technology in the management of standard operating procedures(SOPs) for clinical research. METHODS A self-controlled trial was conducted. Forty researchers involved in clinical trials at a tertiary Grade-A hospital were selected as the research subjects. From October 2024 to March 2025, traditional SOP management was implemented(pre-implementation group), and from April 2025 to December 2025, digital technology-based SOP management was adopted(post-implementation group). The researchers' assessment scores, self-directed learning ability, satisfaction level, and occupational burnout were compared and analyzed between 2 groups. RESULTS Researchers in the post-implementation group achieved significantly higher scores in the theoretical assessment [(90.26 ± 2.83) vs(84.57 ± 2.68)] and practical operation assessment [(91.36 ± 2.73) vs(86.49 ± 3.24)] compared with those in the pre-implementation group, with statistically significant differences(P < 0.05). The scores of autonomous learning ability evaluation in the post-implementation group[(161.22 ± 13.94) vs(136.41 ± 14.72)] were also markedly elevated, with a statistically significant difference(P < 0.01). In addition, researchers' satisfaction with the architecture of the SOP system, acceptance of quality control measures and satisfaction with the actual application effects in the post-implementation group were all significantly better than in the pre-implementation group(P < 0.05). Moreover, occupational burnout scores in the post-implementation group[(33.92±7.41) vs(42.12 ± 8.05)] were lower than those in the pre-implementation group, with a statistically significant difference(P < 0.01). CONCLUSION From the perspective of full-life-cycle management, digital technology is leveraged to empower the standard operating procedures for clinical research, shifting from cumbersome constraints to an efficiency-driven tool. This approach fully stimulates researchers' subjective initiative in learning, alleviates occupational burnout, and provides reference experience for the high-quality development of clinical research centers.