tag:blogger.com,1999:blog-8189895374277303751.post6643869938899471518..comments2023-04-22T21:09:30.165-07:00Comments on Working on and with CDISC Standards: EPOCH expected in most SDTM domains - why that is nonsenseXML4Pharmahttp://www.blogger.com/profile/05523910878300565120noreply@blogger.comBlogger4125tag:blogger.com,1999:blog-8189895374277303751.post-26592792657471564992018-10-13T03:34:46.346-07:002018-10-13T03:34:46.346-07:00Dear Suhel,
In my understanding, the epoch is abo...Dear Suhel,<br /><br />In my understanding, the epoch is about the time of the observation or collection of the information, not about when the AE or CM started or ended. <br />Whether it is useful for the reviewer to know whether the CM that was started before the study and was continued after the study was collected during the "screening" or "treatment" epoch, is something I doubt. I think this also resolved the question about partial dates as these should only occur for events that happened (long) before the study started.XML4Pharmahttps://www.blogger.com/profile/05523910878300565120noreply@blogger.comtag:blogger.com,1999:blog-8189895374277303751.post-13278430740094787972018-10-12T09:05:07.423-07:002018-10-12T09:05:07.423-07:00Hello Jozef,
I really admire your work.
I have...Hello Jozef, <br /><br />I really admire your work. <br /><br />I have bit of confusion in conmed/AE related data where event starts before informed consent and then event is still ongoing at the end of the study then what will be the epoch? (missing?). <br /><br />Similarly, if event start before Informed consent and ends during study parrticipation (e.g. Treatment epoch)then what what will be EPOCH (missing?) <br /><br />Also about partial dates I have seen in many places people mentions if dates are partial then EPOCH will be missing. <br /><br />Can you direct me to appropiate source where I can get information related this topic. <br /><br />Thank you. <br /><br />Regards,Suhelhttps://www.blogger.com/profile/05069666689640960873noreply@blogger.comtag:blogger.com,1999:blog-8189895374277303751.post-43929845795902437462018-10-12T09:01:28.851-07:002018-10-12T09:01:28.851-07:00This comment has been removed by the author.Suhelhttps://www.blogger.com/profile/05069666689640960873noreply@blogger.comtag:blogger.com,1999:blog-8189895374277303751.post-56904616939483527142017-01-05T23:25:47.765-08:002017-01-05T23:25:47.765-08:00As a follow-up...
This week I was working on an SD...As a follow-up...<br />This week I was working on an SDTM submission for a customer. When validating the submission with the software tool the FDA is using (Pinnacle21) I noticed that when one EPOCH in a findings domain, one gets the warning SD1076/FDAC031 "Model permissible variable added into standard domain". When one does NOT have EPOCH in a findings domain, one gets the warning SD1077/FDAC021 "FDA Expected variable not found".<br /><br />So, whatever one is doing (having EPOCH in or not), one ALWAYS gets a warning. Does this make sense?XML4Pharmahttps://www.blogger.com/profile/05523910878300565120noreply@blogger.com