临床研究协调员实践和管理专家共识2024版

Expert consensus on clinical research coordinator practice and management:2024 edition

2022年4月,中国医院协会⁃临床研究协调员(clinical research coordinator,CRC)管理专家指导组(京津冀)正式成立。为规范和指导CRC工作,指导临床试验规范实施,专家指导组组织国内学术领域内专家、学者编写《临床研究协调员实践和管理专家共识》。2022年11月,专家指导组起草专家共识初稿。后经过3轮专家意见咨询,2023年6月份,中国医院协会公开发布《中国医院临床试验机构CRC工作管理专家共识》征求意见稿,面向全行业征求意见。该专家共识基于临床试验实践操作的全流程,重点关注临床研究协调员可被授权的工作内容,规范和指导CRC工作,确保研究者和CRC的良好协作,保护受试者安全,提升我国临床试验研究的质量和效率。

In April 2022,the Chinese Hospital Association CRC Management Expert Guidance Group(Beijing⁃Tianjin⁃Hebei)was officially established.In order to standardize and guide CRC work and guide the implementation of clinical trial standards,the expert guidance group organized domestic academic experts and scholars to compile the“Expert Consensus on Clinical Research Coordinator Practice and Management”.In November 2022,the expert guidance group drafted the initial draft of the expert consensus.After three rounds of expert consultation,in June 2023,the Chinese Hospital Association publicly released the draft“consensus on the management of CRC work in clinical trial institutions in Chinese hospitals,soliciting opinions from the entire industry”.This expert consensus is based on the entire process of clinical trial practice operations,focusing on the authorized work content of clinical research coordinators,standardizing and guiding CRC work,ensuring good collaboration between researchers and CRC,protecting subject safety,and improving the quality and efficiency of clinical trial research in China.