CDISC using SAS OnDemand for Academics_ SAS studio

[ahsa_1983]

Hi everyone,

I have recently started working on the CDISC Files preparation for bioequivalence studies (BE) (For FDA submission).

I wrote required SAS codes to generate all the SDTM and ADaM required domains. I have tested these codes against related CDISC and FDA guidelines for different BE studies using SAS OnDemand for Academics_ SAS studio.

My questions are the following:

1- Can we use SAS OnDemand for Academics_ SAS studio to generate xpt files. If yes, should we validate this software and/ or SAS codes?  or validating xpt files using (PINNACLE 21) is enough.

2-If the answer for the first section of question1 is no, can we use SAS 9.4?

Many Thanks in advance

Regards 

[jenburry]

This is not something that can be done with SAS® OnDemand for Academics and would require a commercial SAS® Software License.  Here is a community post that goes over the permitted uses of SAS® OnDemand for Academics:

What are the permitted uses of SAS® OnDemand for Academics? - SAS Support Communities

[ahsa_1983]

Thanks a lot