d Dadaram
on

 

Forums: SDTM

m Michael
on August 5, 2015

I agree we should be true to the standard as published and this is a minor bug in the config, but in some cases it seems like these decisions follow suit about validation rules evolving.  Once you move to  3.2, this variable is EXPECTED.  CDISC rationale is "For administrations considered given at a point in time (e.g., oral tablet, pre-filled syringe injection), where only an administration date/time is collected, EXSTDTC should be copied to EXENDTC as the standard representation."

It's inevitable that your company will eventually submit in the 3.2 and later standards.  So having EXENDTC not permissible is a short term scenario.   It's always good to look ahead at later standards (especially those which have been published for almost 2 years as is the case for SDTM 3.2) and try to accomodate the current industry thinking when applicable.  The SDTM 3.2 IG revision consider this an additional rule:  

Appendix E: Revision History: Changes from CDISC SDTMIG V3.1.3 to V3.2

"Added point in time rule to EXENDTC; EXSTDTC should be copied to EXENDTC for point in time administrations"

 

j Jozef
on August 5, 2015

The wording "for" and "where" suggests that it should be "conditionally expected" isn't it?

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