A case where protocol version and content are different

Pinnacle 21 Support SDTM
1

Hi MinJi,

I would populate Trial Summary information according your final SAP to describe your data analysis process and results in CSR.

In addition, you should explain your approach in Reviewer’s Guide.

Kind Regards,
Sergiy

2

Thank you very much, Sergiy!

3

Hi, I have a question a case where protocol version and content are different.

In TS domain, the protocol contents differs according to the protocol version and the protocols are applied to the clinical trial.

If so. does the TS domain have to contain all protocol contents or just last version?

Thank you in advance!

Best regards,

MinJi