P21 Community v2.2.0 Configuration "SDTM 3.2"

Philipp

on December 12, 2019

P21

Re: P21 Community v2.2.0 Configuration "SDTM 3.2"

Hi Vincent,

Community 2.2 is an old version that is not supported anymore. SDTM 3.2 was named in that way because rules used in this config weren't published at the time of 2.2 release.

Newer Community 3.0 is available, it is regularly updated and has relevant engines for FDA and PMDA, so we don't recommend using version 2.2.

Thanks,

Philipp

Thanks a lot, Philipp, for…

Thanks a lot, Philipp, for your prompt response. We have some agreement that we previously reached with HAs and we would like to stick to it. When I ran v2.x with Configuration "SDTM 3.2", it appeared that it was for FDA because I did not see those REJECT messages that I got with Configuration "SDTM 3.2 (PMDA)". But would like to confirm with you.

Kind regards,

Vincent

Philipp

on December 12, 2019

P21

Sorry, could you please…

Sorry, could you please clarify, what do you mean by HAs? Health Authorities?

Thanks,

Philipp

Sergiy

on December 13, 2019

P21

Today Community 2.2.0 is not relevant to FDA validation

Hi Vincent, 

Community 2.2.0 was released more than 3 years ago. Today this version is outdated and not relevant to FDA validation.

For example, it does not include new FDA Reject rules and additional 142 new rules for SDTM IG 3.2. Also, algorithms and assignments of many rules were modified. FDA will perform evaluation of your study data using the latest available version of validation rules. Therefore, I highly recommend you to use the same approach to be up-to-date with FDA.

Please note that Community 2.2.0 is also not relevant to PMDA validation. For PMDA submissions, you need to use either the previous Community version 2.1.3 (which corresponds Enterprise 3.0.5 currently utilized by PMDA) or Community 3.x / Enterprise 4.x Engine 1511.6. For new PMDA rules you need to use Engine 1810.3 available in Enterprise 4.x or Community 3.x

Kind Regards, 

Sergiy