Question about 2 SDTM packages separated by part from clinical study

m MinJi

on June 7, 2021

Hi, I have a question about SDTM in a clinical study divided into part.

For example, clinical study includes part1 and part2. And, CSR is made per part.

Therefore, SDTM will be created for each part. Then, is it ok if STUDYID is assigned the same?

Thank you in advance!

Best regards,

MinJi

Forums: SDTM

Sergiy

on July 2, 2021

P21

Hi MinJi,

This decision is per your study Protocol. There are no special guidance I am aware of.

The most important is to keep the same USUBJID for the same person across all studies and data packages.

Kind Regards,
Sergiy

m MinJi

on July 4, 2021

Best regards,

MinJi

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