no Warnings and Errors severity level in validator report (version 3.1.0)

Pinnacle 21 Support SEND
1

Hi Amparo,

A while ago, FDA stopped using Severity for their validation rules. They concern that some users ignore Warnings. However, all validation issues are important. That’s why now you can see only FDA Reject Severity for few validation rules. Now majority of validation rules do not have formal FDA Severity.

Note that PMDA is still actively using issue Severity. Therefore, PMDA validation reports includes Severity for all reported issues.

Kind Regards,
Sergiy

2

Hi Sergiy,

Thank you for the reply.

But for some Pinnacle21 ID use in SEND (e.g. SE2319 and SE1126) are not included to PMDA. how should they do?

Amparo

3

You cannot use PMDA Severity for FDA submissions.

Severity is not applicable to FDA rules anymore. Please consider adjusting format of SEND Reviewers’ Guide.

4

Hi Sergiy,

That makes sense.

not sure if is it appropriate to ask regarding nSDRG at here, but to adjust format of SEND reviewers’ guide is permitted?

thank you!

5

Hi Amprao,

Why not?

We have Reviewer’s Guide tool in Pinnacle 21 Enterprise. Data conformance section for non-clinical data was implemented similar to PhUSE template of Reviewer’s Guide for clinical data as a single table. For many years, none of our Enterprise users complained that they have some problems during FDA submission process.

We don’t need to do any modifications now. It works well with missing Severity for FDA rules.

Kind Regards,
Sergiy

6

Hi Sergiy,

Great ! Thank you for sharing the information.

Amparo

7

H Amprao,

The nsdrg template created by the PhUES team is being updated. It will be out for public review in the next few months. The update includes removal of the errors/warnings section headings, but still allows for using a Rule ID.

8

Hi Debra,

Thank you for the update.

9

Hi Sergiy,

Since there is only FDA Reject Severity, no errors and warnings any more. For messages with no FDA severity and cannot fix, do we need to explain one by one in reviewer’s guide? Thanks.

Kind Regards,

Sissi

10

Hi,

In Pinnacle21 community version 3.1.0, we find that there is no Warnings and Errors severity level in validator report. However the Errors and Warnings findings are part of section in nSDRG. Base on this validator report (version3.1.0), how do we report the findings to nSDRG?

Many thanks,

Amparo