NMPA report Rules sheet Severity column definition

p panpan

on July 20, 2023

We want to know how to define the NMPA Severity class. We think it is from the PMDA validation rules, But it is different.
Such as Rule ID SD0085 severity class is defined as Warning in PMDA, But Error in NMPA.
Thanks.

pinnacle 21 NMPA engine report screeshot

Forums: SDTM

Sergiy

on July 25, 2023

P21

Hi Panpan, P21 does not…

Hi Panpan,

P21 does not provide Severity from NMPA. Those are rather issue Type, rather than issue Severity.

Common interpretation of Severity is potential impact to data quality in terms of processing or analysis. PMDA manages Severity of rules based on impact on their internal processes.

FDA have too many different and diverse teams, tools and processes with different expectations. So, they realized that it's just impossible that all teams can have the same assessment of Severity for each rule in terms if impact on each tool, process or analysis. That's why FDA stopped using Severity attribute for validation rules.

We understand this major property of "data quality" defined by "intended use". Pinnacle 21 team utilizes different property - issue Type - using similar terms. Issue Type means probability of true positive data issues in validation findings. "Error" means that a reported finding is ~100% actual problem. "Warning" means that a reporting finding is a potential issue and needs additional manual review and confirmation.

Again, common confusion is due to 1. using the same terms and 2. the same name Severity for Type.

Historically, FDA and PMDA adopted P21 terminology as "Error" and "Warning" for their needs. It's quite difficult to change existing practice. For example, PMDA understand potentially not perfect practice using terms "Error" and "Warning" for Severity. Also, they agree that "High" or "Severe" and "Medium" are better terms, but transition to them will require changing existing PMDA Guidance documentation and some transition period.

Answering your question, in NMPA validation report you have P21 issue Type rather than Severity from NMPA. Per my knowledge, NMPA does not manage/publish Severity for rules now similar to FDA.

Kind Regards,
Sergiy