On September 16, 2021, the CMDE (Center for Medical Device Evaluation) of the NMPA released the draft of Technical Review Guidelines for the Submission Requirements of Clinical Trial Data for Medical Devices.
The submission of clinical trial data should follow the four basic principles below:
- “Traceability” means that the statistical results reproduced from the analytical database and clinical trial reports should be consistent with the data and code submitted by the applicants
- “Legibility” means that the submitted clinical trial data should be consistent with the information contained in the Case Report Form. If there are any errors detected, the researcher should be informed with record. The researcher should then sign and confirm before the corrected data is uploaded.
- “Easiness to read” means the reviewer‘s level of familiarity and mastery of the submitted data variables and the relationships between the variables in order to carry out a statistical and analytical review. According to the draft guidelines, the submission of clinical trial data should increase the level of easiness to read.
- In general, there is a standard file format for clinical trial data of medical devices such as the original database, analytical database, descriptive documentation and codes that should all be stored in a master folder before submission.
The draft guidelines do not cover the clinical trial data for IVDs and real world data, but only the clinical trial data for medical devices.
By Dora Yang and Jacky Li. Contact Cisema if you would like to know more.