SEND

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.

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.
 vs.

Hi,

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,

Amparo 

hi,

SD1138 is not listed in FDA Validator Rules v1.3, but has been validated in the validation report.
Could you tell me why SD1138 is verified?

Sincerely,