Abstract: Objective To summarize the experience of constructing phase I clinical trial ward with tumor speciality characteristics in Hunan Cancer Hospital, so as to provide reference for the building of phase I clinical trial ward in medical institutions. Methods The phase I clinical trial ward of our hospital was subject-centered and managed by a multidisciplinary team. An efficient management system was developed to ensure the construction including ward management, subject management, research team management, quality control, information construction, etc. Results The establishment of phase I clinical trial ward gave full play to the demonstration role of tumor hospital. There were more than 160 ongoing scientific research programs. The rate of protocol violation was <1%; blood sampling and biological sample time window <0.8%; the incidence of nursing adverse event <0.45% and the satisfaction rate of tumor subjects and family members from third party evaluation >96%. Conclusion An efficient phase I clinical trial ward management system is established based on the characteristics of tumor specialty, and a clinical trial training, scientific research and exchange platform in Hunan Province is built. Its service mode and management system can be promoted to other hospitals to further promote the development of clinical trial throughout the country.

Key words: clinical trial, I clinical trial ward, oncology nursing, GCP