In the cross over study, there are two treatments, 4 periods - So populated ARMCD as A-B-A-B. Coming to ACTARMCD - the subject is not treated for any of the periods. Example : A-B-NOTTRT-B. In this case, ACTARMCD is not match with ARMCD and getting the SD2236, SD2237 messages in the Pinnacle validation report. Please suggest, shall we consider this as false positive or any alternate solution. Also, if the subject Not treated for two periods then ACTARMCD length exceeds 20 characters [A-NOTTRT-A-NOTTRT]. Do we need to restrict length as 20 for ACTARMCD?
Thanks in advance for your suggestions.
Thanks Sergiy. Will provide justification in Reviewers Guide.
With respect to length of ACTARMCD : ACTARMCD length exceeds 20 characters [A-NOTTRT-NOTTRT-NOTTRT]. As per guideline, if the subject is not treated then we have to populate ACTARMCD=NOTTRT. In this case, the subject is not taking the treatment in three periods. So populating NOTTRT as 3 times. Hence the length exceeds 20 characters. Can we shorten the ACTARMCD value to 20 characters or leave as it is?
Yes, I would shorten ACTARMCD to fit CDISC SDTM requirement.
P.S. Josef, this is CDISC requirement which is not related to XPT or FDA at all.
Sorry for misspelling your name.
Could you refer to SAS XPORT specifications about 20 characters limitation? Or any similar FDA requirements which are not derived from CDISC standard?
So, no reference to FDA requirement, but still blaming them.
FDA goal is to make efficient and safe drugs available for public. They use whatever works well and try to avoid unnecessary distractions. Promoting of new technology is out of their primary scope. You appeal to wrong authority.
I have decided to delete all my postings here.
It doesn't make sense discussing the "why" of the FDA character limitations (of SAS Transport 5) on a forum of a company that (in my opinion) tries to block innovation at the FDA to make money.
We can further discuss on a neutral forum like LinkedIn - SDTM experts.
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Hi, This is normal to have…
This is normal to have actual arm is not the same as planned arm for few subjects in the study. You just need to report and explain this protocol deviation in Reviewers Guide.