Derivation DRVFL

Pinnacle 21 Support SDTM
1

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 (LinkedIn Login, Sign in | LinkedIn).

2

Thank you for the reply.

I send also the question to the LinkedIn “SDTM Experts”.

Best regards

Anne

3

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