General Discussion

Hi All,

What is the  difference between Pinnacle21 Enterprise Software version 3.2.1 and version 3.2.2?  Are the changes covered in any release notes?

Thanks,

Srilu

Hello All,

I would like to ask what are the main differences between the free and the paid versions of Pinnacle21?

Thank you,

Konrad

Hi Team,

I have questions regarding FDA business rules:

1.) Does Pinnacle 21 Community Version 2.2 checks for latest FDA business rules? To be more vivid configurations we choose from the Pinnacle, some has FDA in the (), does it mean FDA business rules are considered as well?   

2.) FDA ID present in validator are they obtained from FDA or they created by Pinnacle? 

In 2017 release of FDA business rules I see that FDA ID

When will the Controlled Terminology files for 2017-03-31 appear on the webpage https://www.pinnacle21.com/downloads/cdisc-terminology ?

Thanks

Does Pinnacle21 have a position statement on the completeness of their versions of the SDTM & ADaM ODM.XML files in comparison to the CDISC/NCIt files?  Generally what information was left out or added?  Are all terms guaranteed to be included?  General time frame for availability of the Pinnacle21 formatted ODM.XML files (e.g., 30 days)?

Thanks!

Jon

Dear Pinnacle 21 team,

We're looking to migrate to a newer version of Pinnacle 21, and thus are preparing for installation and validation phase. Because this is effectively open source software/freeware our IT QA department  requires us to perform a source code review.

However, the latest version 2.2.0 nor the previous versions 2.1.3 and 2.1.2 have been posted on BitBucket, so it seems to be lagging behind several versions. This basically prevents us from up-versioning. 

Does anyone know where I can find a complete enumeration of the validation rule types and syntax? 
I have read the 'OpenCDISC Validation Framework' article on this site but was hoping to get hold of more comprehensive documentation of the values the various attributes can take

Many thanks.

Is not Community v2.2.0 compatible with Enterprise v3.0.5?

If yes, what are the differences between these products?

In my recent project, I have some early termination visits in the SDTM domain with SVUPDES = Early termination in SV. Since early termination is considered as unplanned visit, so I did not include that in TV. However, the checker is issuing warning "VISIT/VISITNUM values do not match TV domain data".

Rule SD1023 states that "Combination of Visit Name (VISIT) and Visit Number (VISITNUM) in subject-level domains should match that in the TV domain with the exception of Unscheduled and Unplanned visits."

Is there a revision history document that shows all changes to the application from OpenCDISC v1.0 thru OpenCDISC Community and on to Pinnacle21 Community?

We'd like to review it for our validation effort.

Access to historical release notes would work too.

Thanks!