The drug clinical trial institution of our hospital ushered in the provincial bureau inspection

2022年9月2日Yunnan Provincial Drug Administration inspection team of experts4People to our hospital for drug clinical trial institutions daily supervision and inspection。

The experts who came to the hospital for inspection were Dong Xingling, Ren Feiyu, inspector of the Yunnan Drug and Medical Device Evaluation Center, Zhuang Yanqin, observer, Zhou Zeping, director of the hematology department of the Second Affiliated Hospital of Kunming Medical University。At that time, Xia Jie, deputy director and vice president of the National Drug Clinical Trial Institution of our hospital, Jiang Lijuan, director of the Ethics Committee, Tong Xiaoyun, Director of the Ethics Committee Office, Wan Chunping, relevant personnel of the institutional office and the Ethics Committee Office attended the briefing。

The expert group was carried out by listening to reports, on-site inspection, consulting documents and information, assessment and questioning, etc. At the report meeting, Vice President Xia Jie reported the basic situation of the hospital, the operation and work of drug clinical trial institutions, and Jiang Lijuan, chairman of the Ethics Committee, reported the operation and work of the ethics committee。

During the supervision and inspection, the experts of the inspection team successively went to the drug clinical trial institution, the ethics Committee, the liver disease specialty of traditional Chinese medicine, and the skin specialty of traditional Chinese medicineSOPOn-site inspection and guidance were carried out in the aspects of project operation, file management, site facilities, etc., and suggestions and opinions for rectification were put forward in view of existing problems。

At the feedback meeting, Dong Xingling, leader of the inspection team, gave feedback on the problems found in the supervision and inspection process。Xia Jie Vice president in his speech，The hospital will attach great importance to and seriously treat the feedback of the inspection team，Adhere to problem orientation，Make the list of questions specific，Identify the responsible departments and personnel for the rectification of each problem，Aiming at the shortcomings in the work，Comb carefully，Actively improve，Promote construction by inspection，Further strengthen the management of drug clinical trial institutions in our hospital，Effectively protect the safety and rights of subjects。