"Amanda de Montjoie" <ademontjoie@...> 14-Jan-2009 11:22 To "Amanda de Montjoie" <ademontjoie@...>, "Annamaria Muraro" <amu@...>,...
liz.m.nulton-bodiford...
Jan 14, 2009 5:12 pm
286
CGUN, which is the Global User's Network, is a group that was formed to coordinate efforts across CDISC User groups worldwide. They are looking for volunteers...
All, The CDISC/FDA Pilot which has been ongoing since last Spring is looking for a few additional volunteers. The goal of the pilot is to work with the FDA to...
Hi all, I hope everyone can join us at the first user group meeting of 2009. Below is an agenda for the meeting and directions. Please come ready to share ...
Hi everyone, Â At the end of yesterday's meeting, concern was raised over just how much of what is currently available to the public will be moved over to the...
Mike, Yeah, I raised the concern at the meeting and had previously raised it with Tanyss when that newsletter came out. When she says that CDISC is committed...
Upcoming CDISC webcast on 16 April 09: Standards Aren't Just for Data Anymore: Reap Benefits from a Standards-based Approach to Study and Protocol Design...
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...
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