China Clinical Trial Inspection Result Release For 12 Projects
2023-08-14
As per the “Regulations for the Supervision and Administration of Medical Devices” (Order 739) effective since 2021 and the new “Good Clinical Practice of Medical Devices” effective since 2022, China Shanghai local NMPA conducted the onsite audit on 12 ongoing clinical trials with 19 clinical sites in Shanghai, including 6 clinical trials for Class II projects (3 active devices and 3 IVDs) and 6 clinical trials for Class III projects (4 innovative devices and 2 dental implants).
The inspection results from local NMPA disclose that the basic quality of the clinical trial process is controllable, the content of the information is traceable, and no serious deviation, nor authenticity issues, but there are some compliance issues:
The relevant training certificates for some investigator and member of the ethics committee were incomplete, and they lacked the necessary training on the new GCP;
The information of some informed consent forms did not comply with the guidelines and SOP;
Some subject enrollments did not meet the inclusion and exclusion criteria of the trial protocol;
Clinical trial records for some subjects were not complete and no reasons for revisions;
The storage records of some medical device are not complete;
The records of some adverse events are not complete;
The preservation temperatures of some IVDs are not standardized.
BradyKnows elite team has extensive clinical trial experiences in China, covering the pre-market clinical trials, post-market clinical study, real world study, and IITs. For any questions on your clinical study in China, please contact info@bradyknowsmedical.com.
