Hi all, Since we had a discussion about information being slow to seep out of CDISC when I attended your meeting, I just wanted to let you know that the goal...
Hello, The following question came up recently: The section on formatting time / date value refers to the ISO format- but in the description the IG does not...
We ignore time zone considerations and just translate the date/time as recorded in the CRF or lab report, or whatever the data source is. So, generally, we're...
Take a look and provide feedback. Maybe we can have a separate meeting to discuss our ideas about this new attempt at making the protocol machine readable. ...
Hi all, The CDISC Interchange Call for Abstracts is now open. As discussed at our last meeting they are looking for real world presentation of implementing...
Hi everyone, I know that the answer to this question may not be as simple as people would like, but can anyone summarize where in the process the FDA is in ...
Hi Mike, Well I'll attempt to throw in my 2 cents. A few years ago (2006) the FDA was making a push to require SDTM as a submission standard. This was the...
Mike, Here are a couple additional comments to go along with Chris's. The FDA put the SDTM into an eCTD submission guidance a couple years ago as a way that...
Thanks guys. I appreciate your taking the time to respond.  Mike ... From: rtp_cdisc_owner <jack.shostak@...> Subject: [rtp_cdisc] Re: Rely to rule...
INC Research, a therapeutically focused global contract research organization (CRO) with unrivaled expertise and a reputation for conducting global clinical...
Klofenstine, Kayla
kklofenstine@...
Jun 30, 2009 7:43 pm
311
All, Please place September 1 from 2-5 p.m. on your calendars for the next RTP CDISC user group meeting. The meeting will be held at GSK and below is the...
Hi all, Our group is going to do a webinar on the SAS Clinical Toolkit. See the information below. The SAS Clinical Toolkit: An Initial Review Webinar...
All, At the next RTP meeting on September 1 we were going to have a short overview of the feedback from the Intrachange in July. If anyone within this group...
Hi all, I hope you can join us next Tuesday at GSK. Agenda: - Overview of CDISC Intrachange/CDISC Updates - XML and ODM 101 - Case Studies in Implementing...
Dear CDISC RTP User Group attendes: Thank you all for a great meeting and presentations... I was wondering after one of the meeting discussions (sorry, I...
Hello all, This question has come up in my place of employment. Can one of the ADaM folks offer an opinion please? Please see below. Thanks. Elaine I am...
Hello all. If you are looking or know of someone else who may be in the job market, please see the position description below. We are in need of a few ...
Hi, I had a question with the date and time format in SDTMs. 1.If the seconds have not been collected on the crf. Do we display the date and time as...
From the ISO format it is my understanding that unknown seconds are not displayed, i.e. yyyy-mm-ddThh:mm would be the right format. Peter ... Dr. Peter...
You can register for an online event at https://www.livemeeting.com/lrs/8001420460/Registration.aspx?PageName=33jmxx2kvmhwff03 Event title: Webinar - Clinical...
See the attached study specifications document released this week. http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM189445.pdf...
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