Dajiang.com/Ganzhou Toutiao Client News Correspondent Wang Jun reported: On May 24, the expert group from Jiangxi Provincial Food and Drug Administration visited the South The hospital’s Ganzhou Hospital (Ganzhou People’s Hospital) drug clinical trial institution conducts inspection and guidance. The inspection expert group was headed by Xiong Yuqing, a second-level professor at Nanchang University School of Medicine, with Lin Li, director of the Registration Office of the Provincial Drug Administration, and Liu Linlin, director of the Institutional Office of Nanchang Hongdu Hospital of Traditional Chinese Medicine as members. Dean Liu Yuanfei, accompanied by Jiang Qiuhua, the leader of the institution in charge of the hospital, the hospital’s drug clinical institution office, the person in charge of the ethics committee and some researchers of related projects participated in the special inspection.
Liu Yuanfei extended a warm welcome to the expert group to guide the work, and hoped that the expert group would give careful guidance to the GCP work of the institute and put forward valuable suggestions and opinions. Professor Xiong Yuqing explained the purpose and significance of the inspection on behalf of the expert group of the Provincial Food and Drug Administration.
Subsequently, Xiang Yihuo, director of the GCP Office, made a report on the work of the hospital’s drug clinical trial institution and the implementation of the projects undertaken in the past year; Wang Lifang, deputy director of the ethics committee, briefly reported the work of the drug ethics committee.
The inspection team inspected the GCP institution office, GCP center pharmacy and other venues on the spot, carefully reviewed various rules and regulations, SOP and other documents, drug management and file management, and conducted a question and answer with the staff type interview.
The expert group also randomly inspected an ongoing Phase III drug clinical trial project in the oncology department according to the inspection standards. The experts carefully reviewed the investigator folder and subject files of the inspected project. , data, etc.
After the inspection, the inspection team made a summary of the inspection, fully affirmed the achievements of the drug clinical trial institution of Nanfang Hospital Ganzhou Hospital in recent years, and carried out investigations on the deficiencies and problems found in the inspection. feedback. The person in charge of the Office of Drug Clinical Trials said that he would like to thank the inspection team for their help and guidance on the GCP work of the hospital. At the same time, it will increase training efforts, strengthen the guidance of GCP work in the whole hospital, and continuously improve the level of drug clinical trials in the hospital.