FDA Technical Confomance Guide - null ARM/ARMCD for screen failures and not assigned

c Carol

on January 9, 2015

As you know, FDA Technical Conformance Guide is inconsistent with CDISC SDTMIG regarding populating ARM/ARMCD for screen failures and not assigned. Of course you know better than anyone else that many OpenCDISC FDA validation rules use logic assuming SDTMIG rules of ARMCD = 'SCRNFAIL' and ARMCD = 'NOTASSGN' are used. If we follow FDA guidance (ignoring CDISC), various errors will be triggered that will involve time consuming explanations in the SDRG. Could you please advise if you plan to revise the affected rule logic and, if so, what is the rough timeframe of when we could expect such rule tweaks?

Forums: SDTM

s Sergiy

on January 13, 2015

Hi Carol, This FDA

Hi Carol,

This FDA requirement needs additional clarifications.

Kind Regards,

Sergiy

c Carol

on January 14, 2015

Hi Sergiy, Thank you for your

Hi Sergiy,

Thank you for your response.

I think we will continue to follow SDTMIG and OpenCDISC FDA Validation rule logic and not yet switch to the FDA instructions until we receive such additional clarifications.

Best regards,

Carol