As some of you may already know, NMPA (CFDA) published draft version of IVD Clinical Trial Guideline for feedback on November 22nd, 2018. The draft guideline lists eight requirements for IVD clinical protocol.
- General information
Including product information, time and personnel of clinical trials, relevant information of the sponsors etc.
- Background information on clinical trials
- Study objectives
- Study design
Including clinical trial methods, determination of clinical reference standards or selection of comparative reagents, selection of validation methods (if any), selection of clinical trial institutions, subject selection criteria, sample size estimation, sample size distribution, clinical evaluation Indicators, statistical analysis methods, etc.
- Study management
Including clinical trial procedures, bias control, clinical pre-test training, clinical trial quality control, data management, sample management, analysis of the likelihood of adverse events, and provisions for adverse events and product defect reporting
- Provisions for the amendments of clinical trial protocol
- Ethical issues and descriptions of clinical trials and the text of informed consent (if any);
- Other content that needs to be explained.
For those of you who have gone through this process, or even if you haven't, I'd love to hear your thoughts!
If you have any questions or want more information, feel free to send me a message or email at gpalma@chinameddevice.com.
Thanks!
------------------------------
Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------