关键词: 临床研究管理, 药物临床试验, 伦理审查管理, 质量管理, 信息化管理平台

Abstract: Objective To summarize the experience of clinical research information management platform based on integrated digital thinking mode. Methods The links of project approval, start-up preparation, project implementation, quality supervision, and conclusion were connected, and then the informatization and standardization of the whole process were realized in combination with the guidance of clinical research at all levels. Results The construction of the clinical research information management platform provided high-quality data assets and helped hospital digital transformation. Conclusion The digital clinical research management platform has greatly standardized the process of clinical research in the hospital, realized efficient management of clinical research, and promoted the medical quality, medical scientific research exploration, and the construction and development of clinical disciplines.

Key words: Clinical research management, Drug clinical trials, Ethical review management, Quality assurance, Information management system