隨著中國藥物臨床研究事業(yè)的發(fā)展, 臨床研究協(xié)調(diào)員(CRC)作為新興的行業(yè), 扮演著越來越重要的角色。目前國內(nèi)尚無統(tǒng)一的行業(yè)管理標(biāo)準(zhǔn)與指南, 嚴(yán)重影響了CRC行業(yè)的健康發(fā)展。基于此, 中關(guān)村玖泰藥物臨床試驗(yàn)技術(shù)創(chuàng)新聯(lián)盟/中國藥物臨床試驗(yàn)機(jī)構(gòu)聯(lián)盟起草制定了《臨床研究協(xié)調(diào)員行業(yè)管理指南》, 從CRC職業(yè)基本要求、培訓(xùn)、等級(jí)評(píng)估、工作要求、監(jiān)督管理等方面規(guī)范了行業(yè)行為。

The drug clinical researches develop rapidly in China, and clinical research coordinators (CRCs) play more and more important role in pharmaceutical industry. However, there is no mutually recognized guideline for the industry in China, which restricts the healthy development of CRC industry. The "Guideline on CRC Management Practice" is released by Zhongguancun Jiutai Drug Clinical Trial Technology Innovation Association/Chinese GCP Association to regulate the industry, and it covers the CRC qualification, training, assessment, job requirements, and regulation as well.