SD1202, SD1203, SD1204 (date after RFPENDTC) not addressed in FDA's validation checks

j Joan

on November 19, 2014

Hi,

We pick up these flags a lot, especially in trials that are ongoing, or that have longer monitoring of AEs, etc. However, I'm not finding these violations picked up in FDA's new checks, published yesterday, but OpenCDISC 1.5 marks these as an Error.

FDA seems to care more about comparison with the latest Disposition date than against the date DM.RFPENDTC. So it seems the RFPENDTC comparison would be downgraded in importance. What is the story on this? And can we expect that the check might be downgraded with opencdisc 2.0?

Thank you,

Joan

Forums: SDTM

s Sergiy

on November 24, 2014

Hi Joan, This is the first,

Hi Joan,

This is the first, but not the last release of FDA business rules. Missing and new checks will be added later in regular FDA updates.

Also Sponsor is still responsible for quality of submission data which is not limited to any published lists.

The checks you refer to are still executed in FDA DataFit.

Thank you,

Sergiy

j Jozef

on December 8, 2014

FDA validation checks

One also must distinguish between FDA checks and SDTM/CDISC checks.
FDA checks are owned by the FDA, and should come "on top" of SDTM checks, the latter being owned by CDISC (not by anyone else). So FDA checks do NOT downgrade SDTM checks.

One of the frightening statements during the webinar was "these rules are not final and can change any time". How can we ever implement such rules in our working procedures knowing that they can change any moment and without any notice?
Why did the FDA not do a public review of these rules?

Also a pitty that the FDA did not publish these rules as machine-executable rules. Nowadays it is really possible to do so (there even are some W3C standards for this). Missed opportunity ...

s Sergiy

on December 9, 2014

Hi Jozef, FDA validation

Hi Jozef,

FDA validation rules are based on existing standards and regulatory documents. Their goal is to help you to comply with these requirements.

I am sure that FDA will be happy if somebody can provide them machine-executable rules using W3C or other technologies. So far the only option is an OpenCDISC validator which is a free and open-source tool.

If you see a business opportunity here you can develop an alternative solution to demonstrate benefits of your proposal.

Kind Regards,

Sergiy