Run-In Drug (Placebo) into EX?

m Manolya

on August 28, 2015

Hi all,

If I have a Run-In Period in a study (where only Placebo was given), do we need to list this information also in EX? In the SDTMIG it says that IMP belong into EX. There is no such example for Run-In / Washout Periods. Placebo is not a real IMP, so not sure how to handle this. Some say, it should not be listed, others say, it should. Do you have any experience in this?

Thanks for your help in advance!

Forums: SDTM

s Sergiy

on September 18, 2015

Hi Manolya, Unfortunately I

Hi Manolya,

Unfortunately I am not aware of any clear guidance documents on how handle non-investigational study treatment during Run-In period. I saw many different implementations of such cases. Most users utilize EX domains. However it does not look like a perfect solution. A usage of custom domain could be a better alternative.

Kind Regards,

Sergiy