摘要
目前,我国肿瘤药物临床试验者在临床试验研究的同时需从事临床肿瘤医疗工作,无法确保充足的精力及时间完成质量较高的肿瘤药物临床试验。为提高临床肿瘤药物试验的研究质量及研究者对肿瘤药物临床试验的依从性,我国肿瘤药物临床试验机构结合肿瘤临床试验发展的新要求,与一站点管理组织(Site Management Organization,SMO)公司共同管理及成立肿瘤药物临床试验研究协调员团队,现总结及介绍肿瘤药物临床试验中临床协调员的辅助作用。
At present, the investigator of oncology in China participated in the clinical trial and meanwhile,they should engaged in heavy medical work.,so they cannot ensure that they have enough energy and time to complete the trial with high quality. In order to improve the quality and compliance of oncology clinical trials, the national GCP institution in China with the new requirements of development of clinical trials established the team of clinical research coordinator （CRC） with site management organization （Site Management Organization, SMO） to manage the clinical trial together. This article introduced the role of CRC for clinical trial in oncology.
出处
《中国卫生产业》
2015年第3期78-79,共2页
China Health Industry
作者简介
范颂华（1971-），福建永安人，研究生，研发工程师，医学总监，研究方向：创新药物的临床研究。
