Technical support questions about SEND standard and validation rules

July 11, 2023

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

Exception in thread "main" java.lang.NoSuchMethodError:;


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"

Read More
April 14, 2023

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.



Read More
February 28, 2022


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?



Read More
January 4, 2022

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.

Read More
August 12, 2021


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

Read More
July 12, 2021

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! 

Read More
May 18, 2021

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.

Read More
April 22, 2021

The description of the rule associated with Publisher ID 48 for SEND does not match the text of the rule in the published CDISC SEND Rules v3.0 

SD1079    48    Variable is in wrong order within domain    Order of variables should reflect the order of the variables in the SDTM Model. Variables for the three general observation classes must be ordered with Identifiers first, followed by the Topic, Qualifier, and Timing variables. Within each role, variables must be ordered as shown in SDTM: Tables 2.2.1, 2.2.2, 2.2.3, 2.2.4, and 2.2.5.

Read More
April 12, 2021


We noticed there is an updated to engine FDA (2010.1) in Pinnacle 21 Community, since that some of our datasets are detected issue SD1149. According to the description if the column contain null values a comment must be included in the define.xml to state. May I know how to state a comment in the define.xml? At Spec file, which tabs should describe comment, Variables tab or Comments tab? and what kind of information should be mention? (i.e. there is no value at this column...)

Thank you and best regards,


Read More
Subscribe to SEND

Want a demo?

Let’s Talk.

We're eager to share and ready to listen.

Cookie Policy

Pinnacle 21 uses cookies to make our site easier for you to use. By continuing to use this website, you agree to our use of cookies. For more info visit our Privacy Policy.