Occurrence of blank column under "Severity" in validation report

Sergiy

on September 29, 2020

P21

Hi Rajesh, A while ago,…

Hi Rajesh, 

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.

In addition to FDA and PMDA Severity, Pinnacle 21 will introduce Issue Type attribute for validation issues in reports. This attribute is commonly confused with FDA/PMDA Severity due to similar names of values like Error and Warning. But, let's talk about this later.

Kind Regards,
Sergiy

Thanks

Hi Sergiy,

Thanks for your prompt response with clarification to our comment.

Regards,

Rajesh

(Lambros Analytics)

We had the same issue today …

We had the same issue today (29SEP2020) and thank you Sergiy for the detailed explanation. In addition to this forum post I also like to show programmers in my company the release notes about this change but could not locate it in the "application" or "validation engine" release notes on the 3.1.0 download page. Can you help point me to the right location? 

Best regards,

Yang

When will the changelog be…

When will the changelog be updated to reflect P21C v3.1? The link to the application changes provided on the download page is here:

https://bitbucket.org/p21-community/desktop/src/master/resources/CHANGELOG.txt

However the last update was in October 2019 for v3.0.2.

Trevor

on September 30, 2020

P21

CHANGELOG

We are working to get the CHANGELOG.txt file posted.  In the meantime, here is a list of the changes included:

Pinnacle 21 Community version 3.1.0 (released 28-Sep-2020)

General
- Added support to installer to allow for customized application install location (enhancement)
- Added a 30 day grace period to auto-update to support customized application install location (enhancement)
- Updated the application Preferences to be user specific by storing them in user profiles (enhancement)
- Updated the application Preferences save behavior to improve performance (enhancement)
- Updated the Preferences menu to allow customization of paths for various file types (enhancement)
- Added options to show application and engine changelogs under the Help menu (enhancement)
- Added option to select Source Encoding when validating data for NMPA [Default = UTF-8] (enhancement)
- Fixed an issue that caused the auto-update installation window to be blank (bug fix)
- Fixed an issue where pressing Delete inside a drop-down would cause application to crash (bug fix)
- Fixed an issue that could cause up to a 15 minute delay before validation started under certain internet conditions (bug fix)
- Fixed an issue where Copy and Paste functions were not working on a Mac (bug fix)

Validator
- Updated validation reports generated using FDA engines to only show severity for Rejection rules (enhancement)
- Updated validation report file naming scheme to include seconds and milliseconds (enhancement)
- Added Data Standard details to the Validation Summary sheet in reports when Define-XML is selected as a Standard (enhancement)
- Fixed an issue where Software Version details were not showing up on the Validation Summary sheet in reports (bug fix)
- Fixed an issue that caused a mismatch in counts between the Issue Summary and Details worksheets for rule SD0006 (bug fix)
- Fixed an issue related to rule SD1251 which caused the rule description to be formatted incorrectly (bug fix)

CLI
- Added support for MED-RT with parameter --med-rt.version (enhancement)
- Added support for WHODD with parameter --whodrug.version (enhancement)
- Added support for specifying data encoding for NMPA engine with parameter --source.encoding (enhancement)
- Fixed an issue where not all affected records where listed in the Details tab when --report.cuttoff was used (bug fix)

Define.xml Generator
- Added option to select Source Encoding when creating Excel specification from Source Data [Default = LATIN1] (enhancement)
- Fixed an issue where generating an Excel specification from SDTM/ADaM XPT with Engine 1907.1 would cause Error code 56 (bug fix)
- Fixed an issue where AP domains were getting the incorrect value for ItemGroupDef/@Domain assigned (bug fix)
- Fixed an issue where generating a define.xml from Excel spec would fail with reason: Zip bomb detected! (bug fix)

Dictionaries
- Added support for MED-RT
- Added support for WHODD

Thanks

Does this impact both Community and Enterprise versions?

If the severity column is blank, does this mean all messages have to be explained in the reviewer's guide.

Sergiy

on December 7, 2020

P21

Hi Pramod,  Yes, this is…

Hi Pramod, 

Yes, this is one of the major reasons why FDA stopped publishing Severity for their validation rules. They had concerns that some users incorrectly fixed, reported and explained only Error issues ignoring Warnings.

Kind Regards,

Sergiy 

Update on issue type designation?

Hi Sergiy,

Just curious if there's an update to the "let's discuss later" portion of your response above. It seems P21 Enterprise is displaying issue type, but community is not. A report generated on enterprise appears to have this column for both FDA and PMDA. What is the source of these issue type values if not FDA/PMDA?

We are trying to identify rules for which any issue type might be generated, as we might propose an adjusted severity for the observational research use case in the future.

Thanks!

Jon

Matt

on September 7, 2022

P21

Hi Jon,   Issue Type is…

Hi Jon,

Issue Type is currently only present in P21 Enterprise Validation Reports as this column relates to Issue Management details provided within Enterprise.

Kind regards,

Matt