General Discussion

On https://www.pinnacle21.com/projects/validator/engine-compatibility  you have the following guidance on Engine compatibility

As a sponsor, we collect a separate AE when the severity changes, both worsening and improvement. This becomes especially tricky in the event of worsening, because per FDA rule SD1332, the outcome for the initial event cannot have a value of not recovered/not resolved.  If an end date is not entered, then we will potentially have events with overlapping dates. 

Dear Support,

I have Pinnacle 3.0.2 installed on Windows 2012R2. After few months (probably 3months), the validation does not work with the error message "Error Code 61: System Installation Qualification Error". This exactly happened with the earlier version 3.0.0 as well. I've attached the screenshot for reference. Could you please let me know if there is any expiration on the installation?

Best regards,
Mathias

How long after a new version of the Community software is released is the old client jar file expired?

For background, it appears that if you run P21 Community from the commandline, it will not run if there is no internet connection. If there is an internet connection and you run using an older client jar file, it will give the following exception:

"Installation qualification check Expiration date check failed for GLOBAL"

Hi!

I would like some information about Pinnacle21 On-demand version.
I think there was On-demand version of Pinnacle21 before,
but I could not find it now.
Is this still available?

Thank you.

Kousuke

Hi,

Since we are still using P21 v2.2.0, could you please add the last CDISC Terminology version (eg. SDTM 2019-06-28) on https://www.pinnacle21.com/downloads/cdisc-terminolog ?

Thanks in advance.

Hi,
I just downloaded the new community 3.0.1 validator and trying to validate few XPTs and it says "Validating Data.. " Validation has started" but it seems to be stuck and not progressing.

Previous community Version does validation without any issues. 

Any idea what went wrong?

Thanks.

I was searching for difference in the rules between 2.2.0 and pinnacle21 V3.01 but I could not find much, if there is a list that shows the difference please could you share it? I could find this link  https://www.pinnacle21.com/blog/introducing-p21-community-3 but it is very high level.

We are planning to setup a Virtual Machine with the Pinnacle software
for use by our organization.  We want to maintain  the same set of versions (CDISC CT, UNII, NDF-RT, FDA engine)
for all the reports in a study so we are planning on not having the virtual machine
connected to the internet so the definitions are not updated during a study. 

If we want to update the versions after we complete a study how can we do that?
Does the software check for updates each time it starts or is there some algorithm

Hello P21 Team,

Could you please advise, if Pinnacle 21 validation is supporting command line interface for version 2.2.0 or any plans for not supporting CLI for 2.2.0 or greater version.

Please advise,

Thanks,

Kind Regards,

Ankur