SEND

Hello,

while validate datasets with SEND CT 2019-12-20, software gives non standard terminology warning, but same warning has not been detected when select and validate datasets with SEND CT 2020-03-27. please suggest.

Hi,

We have an issue about SD1082/FDAB018. We use Pinnacle21 community version 3.0.2 to validate our SEND datasets (configuration as IG 3.0) and get errors about "Variable length is too long for actual data". No matter what we do to the value of QLABEL (re-sized the length) the report still give us same result (please find snapshot in the attachment).  or is there any we misunderstanding?

thank you

Best regards,

Amparo

Hi,

I'm curious if we could get a fix (or explanation) for a few validation issues we've spotted in the EG domain for SEND 3.0.  Specifically, the two identified are below:

1.  "Variable is in wrong order within domain" for EGLEAD:  In the dataset, EGLEAD is correctly placed after EGNAM and before EGMETHOD, in accordance with the SEND Implementation Guide 3.0.  

Hi,

we found that there are some issues not be detected at Pinnacle21 v2.2.0.

Our SE dataset is against rule SD1087, SD1091 and SD1092 (our SE dataset only include  8 variable STUDYID, DOMAIN, USUBJID, SESEQ, ETCD, ELEMENT, SESTDTC and SEENDTC) however after verifying we didn't find any warnings.  

does it any workaround?

Best regards,

Amparo  

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.