From December 11 to 13, 2023, a group of four experts from National Medical Products Administration Verification Center, accompanied by relevant staff from Drug Registration Department of Shaanxi Medical Products Administration and Shaanxi Provincial Verification Center, conducted a 3-day on-site data verification on clinical trial project of Lanreotide Autogel undertaken by Department of Oncology of the First Affiliated Hospital (FAH) of Xi’an Jiaotong University (XJTU) in 2021. Vice President Han Suxia, Director Yao Yu from Department of Oncology, Director Lu Mingying from Office of Clinical Pharmacological Institution, project team members including Professor Li Enxiao, Professor Wu Yinying, Physician Yang Jiao, Head Nurse Wu Huili, Research Nurse Ma Haijing and He Ying, and all staff from Office of Clinical Pharmacological Institution and Ethics Office, and representative applicants participated in the data verification process.

Experts carefully reviewed the integrity and standardization of all the saved documents and original records of the project in accordance with the Key Points and Judgment Principles of Drug Registration Verification (Clinical Drug Trial) (Trial) issued by National Medical Products Administration Verification Center, verified the professionalism of project ethics review documents and ethics meeting records, examined the accuracy of inclusion and exclusion criteria, discussed with researchers regarding the standardization of subject participation in the diagnosis and treatment process, and confirmed the consistency of the implementation plan during clinical trials. In addition, they also traced back to medical records and the originality of prescription records of each subject from HIS system, paid attention to combined medication of all patients, assessed the accuracy of judgment, treatment and records of adverse events (AEs) and serious adverse events (SAEs), and traced back to end events of each subject based on efficacy evaluation indexes of the project, checked the preservation and use of experimental drugs, and verified original records of biological sample collection, processing, preservation and mailing. Experts also utilized information technology to connect central laboratory and image evaluation center for remote traceability, compared and evaluated the consistency between samples from central laboratory and results from image evaluation center, and finally examined statistical analysis of the database, etc.

On December 13, a feedback meeting was held. Experts from the verification team delivered explicit feedbacks on several normative problems existing in the clinical trial process. The main problems included the omission of AEs records, inconsistent CS/NCS standards for evaluating clinical significance of abnormal values in laboratory tests, and irregular modification of original records, such as medical records, nursing records and sample collection records. The research team stressed that they will attach significant importance to the problems proposed by experts during this verification process, make thorough correction and improvement, and improve the standardization, scientificity and preciseness of the implementation process of clinical trial projects.