SEND

Hi Team,

I am using pinnacle 21 to validate a SEND define.xml v2.1, but got an Error below: 

DD0073: For Define-XML v2.0, the Origin Type attribute must have a value of 'CRF', 'Derived', 'Assigned', 'Protocol', 'eDT', or 'Predecessor' for SDTM and ADaM data and 'COLLECTED', 'DERIVED', 'OTHER', or 'NOT AVAILABLE' for SEND data. For Define-XML v2.1, the Origin Type attribute must have a value of 'Collected', 'Derived', 'Assigned', 'Protocol', or 'Predecessor' for SDTM and SEND data and 'Derived', 'Assigned', or 'Predecessor' for ADaM.

Dear Support,

Today my P21C validation report shows a problem (the screen shot seen below).

Then I uninstalled my current using P21C and then download the new one (seen below screen shot); and installed it.

But the problem still exists in the validation report.

I'm trying to validate a sample xpt file but I keep getting this error:

Exception in thread "main" java.lang.NoSuchMethodError: sun.nio.ch.DirectBuffer.cleaner()Lsun/misc/Cleaner;

What could I be doing wrong?
Here's the command I am executing:

java -jar p21-client-1.0.7.jar --engine.version="FDA 2204.1" --standard=send --standard.version=3.1 --source.send="C:\Users\User\Documents\practice\bw.xpt" --cdisc.ct.send.version=2023-03-31 --report="C:\Users\User\Documents\report.xlsx" --config="C:\Users\User\Documents\Pinnacle 21 Community\configs"

Hello All,

FDA Validation rules 1.6 were published in December 2022.

I wonder if the newest FDA engine 2204.1 in P21 Community v4.0.1 includes these? I haven't found any documentation so far.

Thanks,

Michael

Hello,

Will Pinnacle21 Community be updated to include validation rules for DART 1.1 and SEND 3.1.1 prior to March 2023, or approximately, when do these upgrades fit into the Pinnacle21 Community roadmap?

Best,

Jason

I have created simplified TS.xpt because study started before 17th Dec 2016. but regulatory colleague has received FDA Technical rejection Error 1736 that describe that we have to submit dm.xpt and define.xml. Because of FDA study date technical rejection criteria March 2021, we got this Error. is it mandatory to include both file even i have started study before date. Please suggest.

Just in case if anybody missed this webinar

https://www.youtube.com/watch?v=o-qjjaeHoqw

Hi

No data in expected variable but i have populated variable to minimize warning from Pinnacle validation. but still pinnacle give message for variable length that shows 0 if i have populated variable with no data how can be possible to change length. 

Variables                   Values                Pinnacle 21 ID                            Message                                                                                  Categroy

This warning (Invalid TSVAL value for STENDTC) populated  for 3.0 study when STENDTC is "NOT AVAILABLE" which I think cased by TSVAL variable is not in ISO 8601 format. 

I wonder what value should put in the TSVAL when Study End Date is not available that won't lead to val tool warnings, because removing STENDTC will cause another warning "Missing STENDTC Trial Summary Parameter". Thank you! 

The FDA publishes Business Rules (currently v1.5, last updated May 2019) and Validator Rules (currently v1.5, last updated March 2021).  Which version of each is covered by Community 3.1.0, Engine 2010.1?  It appears that the landing page indicates v1.5 of Validator Rules is used; just want to confirm.