AD0053 USUBJID value does not exist in the SDTM DM domain

STUDYID is included into AD0053 check algorithm

Hi Yan, 

Algorithm for AD0053 check includes STUDYID in addition to USUBJID. So a current issue message may be confusing and should be changed to "STUDYID / USUBJID value does not exist in the SDTM DM domain"

I assume that your analysis data is not limited to one study. Sometimes a study Open Label Extension (OL) is done under a different Protocol in addition to the first study part like Double Blind (DB). So, tabulation data for actually the same study is submitted into different folders and considered as formally different studies.

Implementation of Analysis data of such studies is quite challenging because there is no perfect solution in terms of current standards, regulations and a company internal practice. In most cases Sponsors combine two formally different studies as a source of Analysis data for the same subjects. eCTD structure has a special folders for integrated data. However, this case of combining just DB and OL phases is not ISS/ISE data for an application. 

The simplest solution would be to keep DB and OL parts of the study under the same Protocol.

Kind Regards, 

Sergiy

Traceability between ADaM and SDTM

Thanks Sergiy.

I am curious about how Pinnacle 21 checks the traceability between ADaM and SDTM.

The message appeared when I checked my ADaM dataset. I only provided my ADaM dataset as the "Source Data".

How does Pinnacle 21 know where to find the SDTM datasets? In the same folder of my ADaM dataset?

Kind regards,

Yan

You need to add AE, DM and EX domains

Hi Yan, 

You need to add AE, DM and EX domains when validating ADaM data.

eCTD structure with pre-defined location of analysis and tabulation data utilized by FDA and PMDA allows automation.

Regards, 

Sergiy

Traceability between ADaM and SDTM

Thanks Sergiy.

So if SDTM data and ADaM data are in the predefined location of eCTD structure, and you check ADaM data with Pinnacle 21, Pinnacle 21 will automatically find the locatins of AE, DM and EX and check the treaceability between ADaM datasets and SDTM AE, DM and EX datasets?

Kind regards,

Yan

FDA and PMDA automated a data validation process

Hi Yan, 

FDA and PMDA automated a data validation process using eCTD structure and metadata available in define.xml files.

A part of this automation is an including AE, DM and EX domains for validation ADaM data. 

As a user of P21 Validator outside of FDA and PMDA you need to add AE, DM and EX domains manually.

Kind Regards, 

Sergiy

Use P21 validator outside of FDA and PMDA

Thanks Sergiy!