validation report in Chinese

Sergiy

on September 2, 2020

P21

Could you clarify your expectations?

Hi John,

We have started implementation for NMPA data validation just a few weeks ago. Engine NMPA 1907.3 is a first draft version. We plan monthly updates expending support for CDISC standards and different encoding for Chinese data; adding new and tuning existing rules; enhancing tool functionality and validation reports.

Today NMPA 1907.3 engine is designed for validation of SDTM study data for NMPA submissions. It supports UTF-8 encoding for Chinese language and generates reports with Messages and Descriptions in Chinese.    

Could you clarify your expectations as possible requirements for new functionallity of P21 Validator

Thank you,
Sergiy

I was expecting English to be the default

I expected the default output to be in English.  That is the language I want for the output.  Do I need to revert to an older version?

Sergiy

on September 2, 2020

P21

Hi John, "I expected the…

Hi John, 

"I expected the default output to be in English"

I think that Chinese users including Chinese regulatory agency (NMPA) do not agree with you. There are very specific requirements about localization of P21 validation for China. We plan to have GUI and validation reports as well as other relevant files like Define.xml stylesheet fully translated to Chinese language. 

Please clarify if you are preparing your study data for FDA, PMDA or NMPA submission? For FDA submission, please use engine FDA 1907.2. For PMDA submission, please use PMDA 1810.3. These engines have output in English.

We are considering full localization as a new functionality to implement later. So, users can select language of GUI interface and reports. However, we think that it's convenience rather than critical functionality. For example, if you work with Chinese data you have to read and understand Chinese language.

Kind Regards,
Sergiy