SEND

Hi,

Just wondering if anyone else has had any issues with the latest two odm.xml CT files not triggering non-CT validator warnings as they should.  I've downloaded the new CT files from the P21 site and installed as usual, but when using either the 09-28 or 12-21 set, the validator is not generating non-CT warnings.

I've tested the same dataset with the 06-29-2018 P21 terminology, and the warnings are still correctly being generated.

I'm using Community v2.2.0.

Best,
Brian

What Version of the FDA's validation rules does Pinnacle check against, and where can i find this information?

Hi,

According to the SEND-IG, Appendix E, the following SDTM variables, defined for use in human clinical trials, do not fit the SEND model and must NEVER be used in the submission of non-clinical studies :

Events:
• BDSYCD
• HLT
• HLTCD
• HLGT
• LLT
• LLTCD
• PARTY
• PRTYID
• PTCD
• SCAN
• SCONG
• SDISAB
• SDTH
• SHOSP
• SLIFE
• SOD
• SMIE
• SOC
• SOCCD

Is it known when a config file corresponding to SENDIG v3.1 will be available?

Thanks,

Amber

Is there anyway to tell what version of the FDA's SEND Validation Rules are being used by Pinnacle 21 Validator to test against the datasets? As far as I know, the most recent version is of SEND Validation Rules is v2.1, and I see the Rule ID (E.g. FDAN001) referenced under Publisher ID in the Validation Report Rule, but is there a way to check which version of the SEND Validation Rules is being used in Pinnacle 21?

A warning SD0018 "Invalid value for CLTESTCD variable" seems to be thrown when CLTESTCD is not upper case.

There is no rule in the SENDIG which requires that entries in this variable be in uppercase text, and CLTESTCD does not use controlled terminology.  It seems perhaps that this rule has somehow been assumed based on controlled terminology in other domain TESTCD entries. 

If there is a source for this rule, please provide this as a reference, otherwise I think this is not a valid check.

Edit: obviously I did something wrong, next time I tried everything worked fine.

It appears there may be an error in the SEND Config file.  Up until Pinnacle21 Community version 2.1.2, the dataset variable types seemed to match the SENDIG.

Now they appear to no longer be in alignment.  This is returning false errors I believe.  I noticed this case in the LB Domain, where the dataset type according to SENDIG is Num or numeric for LBORNRLO and LBORNRHI.  Our LB.xpt file contains this information at the metadata level, but the validator returns error SE0055/FDAN032.  Prior versions had this type as float.

Please check the SENDIG, but I believe that in “config-send-3.0.xml” you should remove the “s” from the end of this line: <ItemDef OID="LB.LBSTNRC" Name="LBSTNRC" DataType="text" def:Label="Reference Range for Char Rslt-Std Units"/>

Bill Houser.

Hi,

SD0007 (Inconsistent value for standard unit) is currently flagged as an Error by the validator.  However, there are legitimate cases where there can be multiple units for a given test in a domain, such as the LB domain in SEND (one sample case is where differing values of LBCAT can have different standard units for the test within the LBCAT; but there are also other cases like LBMETHOD or a random SUPP variable are what keeps them unique).

Please change this rule to a warning.