tag:blogger.com,1999:blog-7186690073755570448.post7497295768068175369..comments2023-11-23T15:04:03.892+01:00Comments on CDISC end-to-end: Submissions in XML - first resultsXML4Pharmahttp://www.blogger.com/profile/05523910878300565120noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-7186690073755570448.post-20337877635274876302013-11-17T15:50:28.172+01:002013-11-17T15:50:28.172+01:00Last sentence should of course have been:
"th...Last sentence should of course have been:<br />"that all non-standard variables should have the name starting with "SUPP", like e.g. "SUPPEFFI" in the LZZT-DM example.XML4Pharmahttps://www.blogger.com/profile/05523910878300565120noreply@blogger.comtag:blogger.com,1999:blog-7186690073755570448.post-61187358396392178382013-11-17T15:47:20.431+01:002013-11-17T15:47:20.431+01:00Hi Lex,
I agree that it is possible, and should ...Hi Lex, <br /><br />I agree that it is possible, and should have been implemented.<br /><br />However, what I understood from some SDTM people, is that that was not acceptable (already long time ago?) for the FDA (which FDA?) as it is not possible to flag those variables as being non-standard within the SAS XPT files themselves. At that time (I mean when SUPPQUAL was first defined) we did not have define.xml either, so reviewers had no way (except for looking into the spec or implementation guide) to find out whether a variable is standard or not when looking at the datasets. Of course one could have used a naming convention (I do not like naming coventions though), e.g. that all non-standard variables should have the name starting with "SUPPEFFI" in the LZZT-DM example. <br /><br />Thanks for pointing me to this!XML4Pharmahttps://www.blogger.com/profile/05523910878300565120noreply@blogger.com