SD2236 ERROR

y Yi

on March 11, 2014

Hi All.

I always get this warning on ACTARMCD for early term subjects on DM domain even though i mapped UNPLAN on ACTARMCD to follow IG.

SD2236

ACTARMCD does not equal ARMCD

A value for an Actual Arm Code (ACTARMCD) variable is expected to be equal to a value of an Arm Code (ARMCD) variable.

Does ACTARMCD have to be the same as ARMCD? If the subject is early termination, how we handle it?

Thank you!

Bessie

Forums: Define.xml

s Sergiy

on March 11, 2014

Hi Bessie, Your example with

Hi Bessie,

Your example with ACTARMCD="UNPLAN" is actually about SD2002 check, which use TA domain as a look-up source for valid ACTARMCD values.

SD2236 is a data quality checks, rather than standard compliance rule. The check's purpose is to report subjects which received other than Planned (ARMCD) treatment. ACTARMCD does not have to be the same as ARMCD. However it is expected result if there is no Protocol Violations in the study conduct process.

Kind Regards,

Sergiy

y Yi

on March 15, 2014