SEND

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,

Hi,

In Pinnacle21 community version 3.1.0, we find that there is no Warnings and Errors severity level in validator report. However the Errors and Warnings findings are part of section in nSDRG. Base on this validator report (version3.1.0), how do we report the findings to nSDRG?

Many thanks,

Amparo

Hii

Received this type of Warning after validate my datasets

FDAB011- Missing DOSENDTC Trial Summary Parameter

FDAB011- Missing DOSSTDTC Trial Summary Parameter

FDAB011- Missing PDOSFRQ Trial Summary Parameter

FDAB011- Missing SEXPOP Trial Summary Parameter

Hello Team,

Can i create STF (study tagging file) from Pinnacle21 community? 

Also please share how to create STF file for define.xml.

Thanks

Hi, I have internet connection in my laptop. In spite of having internet connection in my laptop I always get a message "No internet connection" on the top of the validator.

Can someone help me to resolve this issue?

Thank You

Navin

In the original publication by the FDA (which should be NORMATIVE), the rule definition and error message of FDA rule SE2306 conflict with each other.
The rule definition states: "At least one of the these variables or sets of variables should be populated: (DM.RFSTDTC and --DTC) or --STDY, or --VISITDY".
The error message states: "Missing values for all required set(s) of timing variables [DM.RFSTDTC with --DTC] , --DY and VISITDY".