Interim Data Cuts

Pinnacle 21 Support SDTM
1

Hi Jane,

Sorry for late response. I am not aware of any specific standard requirements or guidance on handling interim data cut in SDTM data.

The only recommendation would be to use SDTM 3.1.3+ versions. RFPENDTC variable can be useful to provide Data-Cutoff date for each subjects.

Also, there is special Parameter in Trial Summary domain: DCUTDTC - Data Cutoff Date

Kind Regards,

Sergiy

2

Hello,

Do you have any advice for users preparing submissions on interim data cuts, other than documenting this in the SDRG?

Interim data cuts can look very non-conforming.

Thanks in advance.

Jane