Essential Abilities and Requirements for Drug Clinical Trial Investigators Based on Legal and Regulatory Frameworks
The Measures for Supervision and Inspection of Drug Clinical Trial Institutions(the Tentative Version)will be imple-mented from March 1,2024,which emphasize the responsibility and risk prevention awareness of investigators,and strengthen punish-ment of irregular behaviors.The inspection results by NMPA show that there are some problems for investigators in their abilities to per-form their responsibilities and quality control of clinical trials,such as lack of qualifications,test conditions cannot be guaranteed,insuf-ficient awareness of Good Clinical Practice(GCP),non-standard informed consent processes and trial records,protocol violations,insuf-ficient 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 pre-vent 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.
Drug clinical trialsInvestigatorResponsibilitiesQuality controlHuman subject rights protection
万方数据
维普
