General Discussion

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"?

Does Pinnacle 21 maintain a list of known bugs/issues for Pinnacle 21 Community?

While looking to download the Controlled Terminology files released in Dec 2015, I found the following note...

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Questionnaires, Ratings, and Scales (QRS) Terminology:

In version 1.x, we used to be able to run OpenCDISC Validator from the command line. Does this still apply to version 2.x of OpenCDISC/Pinnacle 21 Community?

Hi there,

Can you please explain/describe the naming converntion applied to the Validation Rules files?  i.e. "DATA x.x.x (FDA)" vs. "DATA x.x.x (PMDA)" vs "DATA x.x.x"

Users are asking and I'm not sure what to tell them since for example SDTM 3.2 is accepted by the FDA.

I looked around the website and scrolled thru the forums but didn't see any explanations for the naming convention.

Many thanks.

Where is the v2.1.0 source code located?  I checked https://bitbucket.org/opencdisc/ but couldn't find it there.

Since we run from a shared server I want to be able to modify the location of the reports and logs folders (so any tips of what/where to change would also be appreciated).

Thanks!

I have recently been reviewing the list of SDTM validation rules on this website, specifically looking for one rule in particular that used to fire when we ran the Open CDISC validator over SDTM data created from our standard CRFs (SD1118).

When I follow the links to the SDTM validation rules, this rule no longer appears for any version of SDTM. I also note that for version 3.1.2, there has been a note for a while that says the page is being updated.