SD0062 Severity

t Takayuki

on October 11, 2016

SD0062 is defined as the "Reject" by PMDA, but it is the "Error" in P21C.

Is this a bug?

Regards,

Takayuki

Forums: SDTM

j Jozef

on October 12, 2016

SD0062 Severity

I think the "severity" of "Reject" is correct.
I did a search and found https://www.pmda.go.jp/files/000208573.pdf (slides 17 and 18) where this is stated. I did not find the official source for this on the PMDA site (maybe it was not translated yet).
Does the validator state anything else when applying the PMDA rules?

However, the error message let me think. It says "Domain table must have a valid format (e.g., SAS transport (XPORT) v.5 or text-delimited)".
First of all, the wording "e.g." should never appear in a rule. It makes the rule "fuzzy".
Then we read "text-delimited". OK, that's interesting.
It doesn't state what exactly is meant by "text-delimited", nor what the delimiting characters may be. Interesting in this context is that XML is essentially also "text-delimited", as the information is separated (delimited) by ... XML tags, the latter describing what the piece of information is.
So, does this mean we are allowed to submit SDTM in Dataset-XML format to the FDA or PMDA? Unfortunately not ... :-(