Derivation DRVFL

a Anne

on May 17, 2022

Hello,

My question is about calculation within EDC (e.g. BMI). In Define-XML V2.1 type is "derived" and source is "sponsor". In addition should we flag these EDC calculations with DRVFL="Y" ? Or DRVFL is only populated to Y when a new record is added comparing with the source.

Thanks for your help,

Best regards

Anne

Forums: SDTM

j Jozef

on May 17, 2022

Derivation DRVFL

My way (5 cents) ...
If the derivation is done in the EDC system and the investigator can inspect the result, then I do not set DRVFL to "Y", i.e. I consider the data point as "captured".
If the derivation is however done during SDTM generation, I definitely set DRVFL=Y. I presume this is the same as saying "when a record is added comparing with the source".

BTW, this is a question that is better asked at e.g. the LinkedIn "SDTM Experts" forum (https://www.linkedin.com/groups/2758697/).

a Anne

on May 18, 2022