SD0070 - enhance to include looking at ACTARMCD

s Susan

on April 5, 2013

There will be no EX records for subjects who are randomized and not treated. It would be useful if this validation rule would also check to see if ACTARMCD is 'NOTTRT' in addition to ARMCD being either 'SCRNFAIL' or 'NOTASSGN'.

Forums: Validation Rule Suggestions

s Sergiy

on May 13, 2013

Hi Susan, This is a good

Hi Susan,

This is a good suggestion. We thought to implement it.

However FDA reviewers do like this check, which allows them to see a list of randomized subjects who did not received any study treatment.

There are different set of expectations for validation process from Data Management vs. Data Reviewers.

I understand that your goal is to ensure that no errors were made during a preparation of a study data package. It's QC process.

FDA people want to see any types of study data issues. Some of them are more kind of data composition reports. The SD0070 check is the example.

We are still discussing what is the best way to handle the case you described? There are many options to introduce a more intelligent approach to fit expectations of all involved parties.

Regards,

Sergiy