SD2023: AGE is not provided

Pinnacle 21 Support SDTM
1

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

2

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