Question about 2 SDTM packages separated by part from clinical study

Pinnacle 21 Support SDTM
1

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

2

Thank you, Sergiy.

Best regards,

MinJi

3

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