Interim Data Cuts

j jane

on February 9, 2015

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

Forums: SDTM

s Sergiy

on February 24, 2015

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

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