关键词: 药物临床试验, 研究者, 职责, 质量控制, 受试者权益保护

Abstract:

The Measures for Supervision and Inspection of Drug Clinical Trial Institutions （the Tentative Version） will be implemented from March 1， 2024， which emphasize the responsibility and risk prevention awareness of investigators， and strengthen punishment of irregular behaviors. The inspection results by NMPA show that there are some problems for investigators in their abilities to perform their responsibilities and quality control of clinical trials， such as lack of qualifications， test conditions cannot be guaranteed， insufficient awareness of Good Clinical Practice （GCP）， non-standard informed consent processes and trial records， protocol violations， insufficient protection of subject rights and interests， and inadequate quality control and so on. In order to improve the quality of drug clinical trials， this study emphasizes the importance and necessity of conducting clinical trials， and based on the current GCP requirements for investigators， it also explores the essential abilities of investigators， such as how to protect the rights and safety of subjects， how to prevent risks， strict compliance with protocols， strengthen systematic training to master trial techniques， GCP and other relevant regulatory knowledge and so on. This study proposes the mission of investigators in high-quality development period in order to strengthen the sense of responsibility among investigators， especially the principal investigator （PI）， and promote the high-quality development of clinical trials.

Key words: Drug clinical trials； , Investigator； , Responsibilities； , Quality control； , Human subject rights protection