On November 16-17, 2020, an inspection team from the Zhejiang Provincial Drug and Cosmetic Review Center conducted a supervision and inspection of drug clinical trial institution filings in our hospital. The inspection team consisted of four senior inspection experts, who conducted a comprehensive and systematic assessment of the professional groups in our hospital for this new filing.

Professor Ye, President of Shulan（Hangzhou）Hospital, reported on the basic situation of the hospital at the first meeting. Chen guiling, Director of the Institutional Office, and Yang Li, Director of the Ethics Office, reported on the development of institutional and ethical work since the qualification in 2018. 13 new specialties were added to the record in Shulan（Hangzhou）Hospital. The heads of the specialties of general surgery, nephrology/renal transplantation, respiratory medicine, endocrinology, gastroenterology, liver transplantation, phase I clinical trial research laboratory (phase I The heads of the specialties of general surgery, nephrology/renal transplantation, respiratory medicine, endocrinology, gastroenterology, liver transplantation, phase I clinical trial research laboratory (phase I drug clinical trials, bioequivalence trials) and medical imaging (X-ray diagnosis, CT diagnosis, magnetic resonance imaging diagnosis, nuclear medicine) reported on the basic situation of the construction of drug clinical trials in their specialties in turn.

After the first meeting, the inspection team conducted on-site questioning and assessment of the personnel of the drug clinical trial institution and the ethics committee, and inspected the relevant system documents and facilities and equipment at the office of the institution, the pharmacy of the GCP Centre, the data room of the GCP Centre and the office of the ethics committee. On-site inspection and data review were conducted for the 13 new professions on record, focusing on the software and hardware conditions (including the construction of the documentation system of the professions, the qualification and training of researchers, and the equipment related to first aid) and the mastery of GCP knowledge for each profession group to conduct clinical trials, and targeted comments and suggestions were made.

The final meeting was held at 15:30 on the afternoon of the 17th in the large conference room on the 1st floor of Building 2. The inspection team gave feedback on the overall situation of the inspection and gave full recognition to the work of our hospital on drug clinical trials, while also pointing out the shortcomings of our work.

In response to the inspection team's comments and suggestions, President Ye made it clear that the hospital would carefully sort out the shortcomings in the work, implement the corrections one by one, and form a correction report to the Zhejiang Provincial Drug Administration as soon as possible. At the same time, each professional group should take this supervision and inspection as an opportunity to make the work of drug clinical trials reach the requirements of standardization and standardization and ensure the quality of drug clinical trials.