临床试验的重要角色:临床研究协调员

Key role in clinical trial: clinical research coordinator

临床研究协调员(CRC)在国外作为临床试验中的一员和一项专门的职业已有30多年历史。CRC主要由护理、药剂等生物医学专业背景的人员担任。CRC的工作范围涉及到临床试验的各个方面,包括试验的准备,与伦理委员会和申办者的联络,协助试验实施的各项工作,如获取知情同意,与患者及其家属的教育、联络、咨询与商谈,数据收集与CRF转录,以及临床检查、不良事件、试验药物、文件资料等管理,应对监查、稽查与视察。CRC对确保临床试验的伦理合理性、科学性及试验数据的可信度方面起重要保证作用。

Clinical research coordinator （CRC） has been an important role in clinical trial and as a profession for almost 30 years in foreign countries. Most CRCs have professional backgrounds of nurse, pharmaceuticals and other biomedical specialties. CRC＇s scope of work involves each aspects of clinical trial, including preparation of clinical trial, liaison with IRB and sponsor, and assisting in the operation of trials, such as obtaining informed consent, diseases management education, liaison, consultation and discussion with patients and their families,data collection and clinical examination, CRF transcription, adverse event, trial management of medicine, clinical trial files and other materials, as well as responding to monitor and audit and inspection. CRC plays an important role in guaranteeing the ethic and scientific rationality, and the reliability of data in clinical trial.