trials, the CRS is required to prepare protocol synopsis, finalize protocol, to be a clinical lead in a study team, prepare and finalize local clinical study report to support local NDA submission.

• 在支持临床研究方面，CRS需要准备研究方案大纲、稿研究方案，在研究团队中起到临床方面的先导作用、备和定稿国内研究报告，支持国内的新药上市申请。