e Edward
on

 

I have submitted a test submission of SDTM data to the FDA for a study.  The FDA has responded with comments.  They also ran their own Pinnacle 21 validator report against the data.   The Pinnacle 21 report that the FDA ran contained more items/issues than I came up with; they had errors that hadn't appeared in my report(perhaps due to the way it was configured).   With that said, there were no REJECTS in the Pinnacle report, and the submission did not fail the Technical Rejection Criteria.   Can the ERRORS that now appear in the FDA report, can they just be explained in the SDRG and the SDTM data be submitted without change/rerun?  Will the data be accepted by the FDA with the ERRORS in the Pinnacle report if comments explaining what the issue is?  I ask because the data is locked and reports have been created on the data that was submitted.  

Forums: SDTM

b Brian
on August 21, 2018

Do you (or anyone) know if they are using the same SDTM Terminology XML files that are available for download from the Pinnacle21 website?  It would be interesting if they could provide you with the file they used.  If the files they use are not the same, then it would be great for the FDA to provide some details.

Would you be able to characterize some of the new errors that they found?

s Sergiy
on August 24, 2018

Hi Brian,

Yes, CDISC Control Terminology is unstable across versions. We are working on this challenge.

Kind Regards, 

Sergiy

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