Key role in clinical trial:clinical research coordinator

Abstract

Abstract: 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 CRF transcription, management of clinical examination, adverse event, trial 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.

Key words: clinical research coordinator, study nurse research nurse, study coordinator site coordinator, clinical trial

CLC Number:

R969

BO Qing-yan, XIONG Ning-ning, ZOU Jian-dong, JIANG Meng, LIU Fang, WANG Xiu-qin, GAO Wei-min. Key role in clinical trial:clinical research coordinator[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2006, 11(10): 1190-1193.

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