CDISC datasets from R. Why not? [Software]

posted by WhiteCoatWriter – India, 2019-03-21 12:13  – Posting: # 20065
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(edited by WhiteCoatWriter on 2019-03-21 12:24)

» Correct. The FDA nowhere mandates SAS or recommends any particular software. E.g., Certara provides the Phoenix CDISC Navigator for import/export in Phoenix/WinNonlin.

While Phoenix needs an additional package to be purchased, I feel that the same can be done by creating tables on phoenix(or importing in .csv) and exporting it to .xpt without the specific package which I assume will only help with limited datasets.

» If you are an experienced R-coder, consider writing a package (see here and there). The community will love you.

I might not be an expert coder/programmer, but I have been working on this for quite some time. Thank you for the references, will definitely try doing something. It really has been a challenge to get it validated using pinnacle validator. Also, when it comes to Adam datasets it specially requires SAS date format which I assume is not possible to be created on R.

While No other regulatory mandates datasets for Bio equivalence study, I still keep wondering what really sparked the USFDA in the mid of Dec 2016 to make CDISC datasets mandate for regulatory submission.

Thanks and Regards
Dr Anonymous

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