European Chamber comments on (draft) Procedures and Key Points for On-Site Inspections of Clinical Trials

2016-04-25 | Beijing

Industry welcome detailed guiding documents on HOW and WHAT that on site inspection of medical device clinical trials will be fulfilled. The two draft documents indicate the process and key points for the inspection. However, for some of the requirements, industry suggests to have further clarification. For instance, the scope of application for the two documents, etc..

36 pieces of concrete suggestions in total 10 pages were consolidated from members.

Should you require further clarification, please kindly contact at hce@europeanchamber.com.cn