General question about "DATA x.x.x (FDA)" vs. "DATA x.x.x (PMDA)" vs "DATA x.x.x"

s Stéphane

on December 16, 2015

Hi there,

Can you please explain/describe the naming converntion applied to the Validation Rules files? i.e. "DATA x.x.x (FDA)" vs. "DATA x.x.x (PMDA)" vs "DATA x.x.x"

Users are asking and I'm not sure what to tell them since for example SDTM 3.2 is accepted by the FDA.

I looked around the website and scrolled thru the forums but didn't see any explanations for the naming convention.

Many thanks.

Forums: General Discussion

b Brad

on December 17, 2015

Indicates Publication

Hi Stéphane,

The rule config files are named that way to indicate publication.

DATA x.x.x (FDA) indicates a rule set that was officially published by the FDA

DATA x.x.x (PMDA) indicates a rule set that was officially published by the PMDA

DATA x.x.x indicates a rule set that is published by Pinnacle21

In the case that you are working with a version that does not have an officially published rule set for the regulatory agency, use the Pinnacle21 rule set. For the specific case you mentioned, SDTM 3.2 submission to FDA, use the Pinnacle21 rule set (“SDTM 3.2”). This represents the best conformance rules for this standard version based on what we believe the FDA will publish, but these rules have not officially been published by the FDA yet.

This information can be found in the PMDA Official Validation Rules webinar at https://www.youtube.com/user/pinnacle21llc

There should be a pinnacle21 blog post about this soon with the slides.