SEND

Hi everyone,

Using the new engine 2405.2, I found a new warning in dataset validation on the value of TXVAL when TXPARMCD = 'TRTDOS'. In this case, I have a dose expressed as a character because it is a concatenation of two doses, because the subject took two different doses of the treatment. Is there a way to manage this warning or have I to only justify that on nsdrg?

Thank you everyone for the response

Dear Team,

We have conducted 4 cycle repeated dermal local tolerability study in minipigs. As per study design, one animal receives six types of treatment at once i.e. untreated, control, saline and placebo control and three type of different strength of compound. Do we required SEND for this type of typical study design or not?. If you guys any idea please suggest.   

While validating SEND Datasets with Pinnacle 21 Community v4.1.0 and FDA Engine 2304.3, there is a warning for "Invalid value for TXVAL for TRTDOS" (SE2366) that is triggered by a TRTDOS value of  "0" for our control group SET.  This has been our practice to use "0" to represent the treatment dose for the control group and has not given a warning before. We consider "0" numerical which falls within the confines of the rule.  Is there any reason this is being flagged by Pinnacle now?

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