SD2023: AGE is not provided

s Saurabh

on March 6, 2017

Hello,

I am receiving error SD2023: AGE is not provided [Age (AGE) variable values should be provided, when Date/Time of Birth (BRTHDTC) variable values are populated.]

But according to IG 3.2 DM-Page No: 6; DM Example 1 – General Demographics, I may not have AGE values for screen failure subjects even though having BRTHDTC information.

Can you please look into SD2023 validation rule?

Thanks

Saurabh

Forums: SDTM

s Sergiy

on March 6, 2017

This is a review-specific check

Hi Saurabh,

This is a review-specific check on top of CDISC compliance. Age is a common Inclusion criteria in study Protocols. Sponsor needs to confirm that a subject screening process was executed correctly.

For Screen Failures a Age calculation algorithm is usually different compare to randomized subjects. For example, date of Screening Visit may be used instead of date of Randomization or the first Dose of study drug.

Kind Regards,

Sergiy