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
Forums: General Discussion
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Hi Ahmad, You can use any…
You can use any software to generate datasets for FDA submission. However, you need to confirm that your software and process are compliant with CRF 21 Part 11 requirements.
Pinnacle 21 validation is not related to software validation.