General Discussion

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!

Hi, 

When is the new version being released, awaiting the inclusion of analysis result metadata for ADaM define v2.0.

Thank you, 

Aadesh Shah

4.1.2.9 Variable Lengths
Very large transport files have become an issue for FDA to process. One of the main contributors to the large file sizes has been sponsors using the maximum length of 200 for character variables. To help rectify this situation:
• The maximum SAS Version 5 character variable length of 200 characters should not be used unless necessary.
• Sponsors should consider the nature of the data, and apply reasonable, appropriate lengths to variables. For example:
o The length of flags will always be 1

There has been a large amount of postings about "label mismatch" in the last weeks and months in this forum.

Time to take a step back and to do a reflection.

Why are labels on variables there? They are there to let the sponsor explain the reviewers what the variable is about. The validator however requires them to be exactly as printed in the SDTM- or ADaM-IG, character by character and even byte by byte. Even an uppercase changed into a lowercase leads to a validation error. Does this still allow the sponsor "to explain what the variable is about"?