关键词: font-size:medium, ">临床研究协调员；药物临床试验；质量控制

Abstract: As specific participant in clinical trials， the operational ability and professional competence of clinical research coordinator (CRC) directly affects the quality of clinical trials. In order to improve the quality of the drug clinical trails， based on the quality control experience of drug clinical trials，this article summerized the common quality problems related to CRCs during the implementation of drug clinical trials， such as qualifications and authority， data recording， file management，drug management， biological sample management and subject management. CRC in China is still at the stage of development， and there are some defects such as lack of industry standards and uneven capacity. Both the clinical research institution and the sponsor should take counter measures to further ensure the scientific， rigorous and standard of clinical studies, such as siting management organization (SMO) optimization system and CRC admittance and training system， establishing the information platform of clinical trials， strengthening quality control and subject protection.

Key words: font-size:medium, ">Clinical research coordinator； Clinical trial； Quality control