INVESTOR NEWSLETTER ISSUE N°3
“Standards-based EHR-enabled applications for clinical research and patient safety: CDISC – IHE QRPH – EHR4CR & SALUS collaboration.” The presentation was well attended, well received, and held CDISC and our IHE partner in the best possible light. I am a co-author of the paper, which is under consideration for ‘best of show’ awards. This paper is a recognition of CDISC’s participation in the EHR4CR project, and our strong representation in Europe.
CDISC received other mentions during the conference, and is increasingly recognized as an essential ingredient for conducting research in general, and in leveraging EHRs for research as an emerging strength.
CDISC UPDATES
Read below for the monthly Technical Update, additions to our CDISC Membership, news from our global CDISC Coordinating Committees and User Groups, upcoming Education and Event opportunities, and other major announcements. This month, we have information on a Tufts survey
April CDISC Technical Update Wayne Kubick, CDISC Chief Technical Officer The CFAST program has experienced its busiest month yet, with the release for comment of new Therapeutic Area User Guides for Diabetes (comments due 12 May) and Cardiovascular Disease (comments due 22 May), both available here. In addition, the Multiple Sclerosis Therapeutic Area Data Standard User Guide v1.0 is being prepared for provisional release in the coming weeks.
The CDISC ADaM team has likewise been very busy, and is about to release for public comment a new Occurrence Data Structure (ODS), which builds upon and expands the current ADaM Adverse Event model (ADAE) to accommodate other types of occurrence data. Following on the heels of ODS is v1.1 of the ADaM Implementation Guide, with an upcoming Analysis Results Metadata Specification for Define-XML v2.0 currently undergoing internal review. The ADaM team is also beginning to contribute analysis models for CFAST therapeutic area standards, beginning with Diabetes and QT Studies.
CDISC WEBSITE LINK
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Also being readied for public review is the first batch of new domains planned for SDTMIG v3.3. Controlled Terminology Package 18 has just completed public review.
Finally, the Dataset-XML v1.0 Specification, formerly known as StudyDataSet-XML, is being readied for posting as Final. An FDA pilot to evaluate Dataset-XML as a potential replacement for the SAS V5 Transport format has just gotten underway, and CDISC is very encouraged to see a number of new software tools being made available to work with this exciting new data exchange standard.
To view the schedule for upcoming releases of CDISC Foundational and Semantic Standards, please see the Technical Plan Project Schedule here.
User Network & 3Cs Update CDISC Japan User Group (CJUG) We were informed by Mr. Yoshiteru Chiba of CJUG that as of this October, the University of Tokyo’s School of Public Health will begin a course on the CDISC standards! The course will cover information on SDTM, SEND, ODM, CDASH, ADaM and more. Several familiar faces will be involved in instructing the course; please see the image below for details.
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Hiroshi%Ohtsu% (Juntendo%University)% (CJUG%ADaM%team%member)
CJUG also held their annual “CDISC Workshop” event on 28 March 2014 at Shinagawa R&D Center at Daiichi Sankyo Co., Ltd. This conference, open only to CJUG members, was attended by 95 people. Keynote addresses were made by Ms. Yuki Ando of the Japan PMDA and Dr. M. Sano of Tokyo University. Topics ranged from regulatory information to updates from standards team members.
Lastly, the monthly CJUG SDTM team meeting was held on Friday, 18 April at Nippon Kayaku Co., Ltd. The meeting was attended by 71 individuals, and seven new members joined at this event. This brings the total number of CJUG SDTM members to 102.
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