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2 Jul 2014

Below is an interview with Dr. Wenjun Bao, Chief Scientist and R&D Manager of JMP Life Sciences in SAS Institute, Inc. Dr. Bao is also a member of the China CDISC Coordinating Committee (C3C).


Congratulations on winning the second place at this poster competition. Why do you think the judges see a winner in this poster?

The poster is titled, “The application of CDISC standards in adverse events analysis,” and was coauthored with Dr. Qin Huang and Dr. Jun Wang of CFDA. The judges really like what the software can do and how it can benefit the whole clinical trial study. They feel that JMP Clinical will enhance the clinical trial data analysis and quality, and make it possible to quickly find meaningful signals in safety data.

2 Jul 2014

Shannon Labout (CDISC VP, Education) and I continued our trip from Shanghai to Tokyo, which took all day, but that seemed short compared to the trip to Shanghai (which took 19 hours longer than scheduled). We arrived at our hotel around 6:30 in the evening and promptly went to eat one of our favorite meals in Japan – okonomiyaki. This comfort food (basically a cabbage pancake that one cooks at ones own table on a small metal grill) was just what we needed to prepare us for the following day.

1 Jul 2014

Team CDISC made an official appearance at the CISCRP Medical Heroes Charity 5K run  held at the beautiful San Diego Embarcadero waterfront at 6:30am on Monday, June 16.  To my recollection, this is the first time that such an activity  — as distinguished from the usual cocktails and hors d’oeuvre fare — has been held at a DIA meeting.  Wizened DIA veterans are well aware of the delicate dance of trying to inconspicuously detect the names associated with semi-familiar faces encountered on the exhibit floor — the classic line is to ask "who are you working for these days?” as you study the badge without disclosing that you’ve also forgotten their name.  And if you think that’s hard, imagine trying to recognize these once a year acquaintances when they’re dressed in shorts, tee shirts and sunglasses rather than business attire — sans name badge.  Lots of waving and close-lipped smiling as you rapidly but fruitlessly scan your memory banks.


1 Jul 2014

Released on 5 June by the New England Journal of Medicine (NEJM) is an article co-authored by Dr. Rebecca Kush (CDISC) and Dr. Michel Goldman (IMI). This article looks at the role that data standardization in clinical research can play when considering data aggregation, reuse and adverse event reporting - all with the goal of utilizing precious patient data to its fullest extent. The article has been published in the NEJM Perspective, available on the NEJM website here.

1 Jul 2014

During May and into June, the SHARE team will continue to be busy on a number of fronts. In June we plan to begin beta testing the eSHARE site for machine-readable downloads of the CDISC standards. The eSHARE site will be part of the new CDISC web site that will be launched in June. The SHARE team has also been actively designing new forms of standards content for SHARE, including Research Concepts and explicit Value Level Metadata representations. A white paper describing our initial solution for Research Concepts will be distributed for review in June. Also during June, we plan to complete an initial proof-of-concept project toward a long-term Research Concept solution. Value-Level Metadata (VLM) blog postings started in May and will continue through June. We plan to publish a white paper describing how VLM content will be represented in SHARE, and exported in Define-XML format later in the summer.

22 Apr 2014

CDISC Europe Interchange Success:

It is always a great pleasure to play a key role in planning and organizing for the CDISC Europe Interchange with the European CDISC Coordinating Committee (E3C). The 2014 Europe Interchange reached the highest attendance rate since 2008, with 100 additional attendees compared to the 2013 Europe Interchange. Over 300 people came to attend this event from 21 countries. The highest attendance rates were from France and the United States, followed by Belgium, Germany, United Kingdom, Denmark, Switzerland, China, Japan, South Korea, South Africa, Netherlands, Czech Republic, Portugal, Poland, India, Italy, Finland and Austria.


New education courses were offered this year. Six courses were offered on Monday and Tuesday, and three were held on Friday. Due to high demand for CDISC SDTM and Define-XML courses, additional classes were open to allow for more registrations.


   Registration Desk - Photo by Diana Harakeh


 SHARE Phases

21 Mar 2014

The 2014 CDISC Winter Intrachange was held February 25th – 27th in Silver Spring, Maryland. CDISC Intrachanges are informal CDISC cross-team meetings for CDISC standards development teams, as opposed to Interchanges, which are yearly conferences, focused on presentations and the sharing of implementation approaches and experience.


Katzenbach and Smith (2008) define a team as, “a small number of people with complementary skills who are committed to a common purpose, set of performance goals, and approaches for which they hold themselves mutually accountable.”


Photo by Rhonda Facile


13 Feb 2014

SHARE is no longer merely a vision, idea, or plan. After nearly 6
months of implementation work SHARE R1, our first production library,
has been completed. Woot woot! This is a major milestone. We've taken
the first step on a long journey towards realizing the vision of
transforming the CDISC standards into an end-to-end, interoperable set
of metadata all available in a machine-readable format.


SDTM 1.2 (IG 3.1.2) and CDASH 1.1 have both been loaded into the
production SHARE Library. Using SHARE R1 we will load SDTM 1.3 (IG
3.1.3) and SDTM 1.4 (IG 3.2) in the coming weeks. Although the CDISC
Controlled Terminology development and governance processes will remain
unchanged, we will continue to load each newly released terminology
package into SHARE. BRIDG 3.2 and the ISO 20190 data types have also
been loaded into the R1 library.

12 Feb 2014

Being a metadata curator means most won’t exactly understand what you do. You can certainly forget about explaining your job to your mom. Traditionally, curators have managed collections of old stuff, like what you might find in a museum. In today’s world of informatics and big data, however, metadata curators play an essential role in enabling metadata driven automation and semantic interoperability.


At CDISC we are implementing the SHARE metadata repository to manage the latest standards metadata, as well as the older stuff. The SHARE metadata curators will play a critical role in defining and administrating the processes and policies for governing the metadata that will become the CDISC standards. They will help to lead the CDISC community towards new ways of standards development. In this capacity, the metadata curator must be a passionate advocate for clinical research data standards, a strong communicator, as well as an energetic collaborator. Since SHARE represents a new approach to standards development, creative chops are a must.

4 Feb 2014

While the news on World Cancer Day has focused on the illusive cure
to cancer, I would like to shed some light and bring necessary attention
to one of the main ways that we as a global society of patients can
actually work to ensure the faster development of therapies: the
implementation and utilization of clinical research standards.


On this day, World Cancer Day 2014, we would like to
pause to thank our volunteers, whose tireless efforts developing
standards for clinical research are working toward real change to
shorten the drug development timeline, bringing new and more effective
therapies to patients more quickl