关键词: font-size:medium, ">药物临床试验；备案；新专业；标准；药物临床试验质量管理规范(GCP)

Abstract: Objective： To establish self-assessment standards for recording the new majors in drug clinical trials and explore effective implementation methods in the new situation. Methods： In accordance with relevant laws and management requirements， Meanwhile， combined with our more than 10 years of management experience， multiple qualification reviews and new professional inspection experience. Our self-assessment standards were established based on the research team， professional conditions and implementation equipments， management systems and standard operating procedures， quality and risk managements， etc. The internal self-assessment team was established to conduct the on-site assessment for new majors. And the on-site assessment report was the crucial basis for whether or not is permitted for recording. Results：The complete self-assessment standards for new majors were established. Via the on-site assessment of the self-assessment team， 15 of the 19 majors applying for records passed the self-assessment. The number of majors that were basically qualified was six， the number of majors that were improved and re-evaluated was two， and the number of majors that were not qualified was two. Conclusion：The self-assessment standard for recording new majors is highly enforceable， and the record managements own certain reference significance.
    

Key words: font-size:medium, ">Drug clinical trial； Practice of record； New majors；Standards； Good clinical practice