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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

21 Oct 2013

On 16-17 September 2013, the Duke Center for Health Informatics (DCHI)
hosted a two-day meeting for high-level strategy discussions pertaining
to the Essential Standards to Enable Learning (ESTEL) initiative of the
Learning Health Community. This was the third face-to-face meeting
focused on the ESTEL initiative, led by the Clinical Data Interchange
Standards Consortium (CDISC). Participants from universities, clinical
research organizations, biopharmaceutical companies, technology
companies, service providers, standards-developing organizations and
related healthcare entities travelled from as far away as the United
Kingdom and California and also included a number of prominent
organizations from Duke's backyard such as North Carolina Health
Information and Communications Alliance, Inc. (NCHICA), SAS,
GlaxoSmithKline and Quintiles. The multi-stakeholder participants, who
share a dedication to collaboratively realizing a national-scale
Learning Health System (LHS), worked together over the two days to build
consensus on a framework for identifying and developing an essential
set of standards to empower stakeholders across the healthcare and
health IT spectra to realize the LHS vision. Collaborative work
included reviewing current learning projects and identifying
standards-related lessons learnable from them; identifying potential
barriers to success and corresponding ways to surmount them; further
developing a scope for the ESTEL initiative; and strategizing around
next steps culminating in concrete actions promising to make meaningful

26 Sep 2013

In July 2004, FDA Commissioner Lester M. Crawford, FDA Commissioner
announced the desire of the FDA to receive data in a standard format,
the CDISC SDTM. "The importance of a standard for the exchange of
clinical trial data cannot be overstated," said Dr. Crawford, "FDA
reviewers spend far too much valuable time simply reorganizing large
amounts of data submitted in varying formats. Having the data presented
in a standard structure will improve FDA's ability to evaluate the data
and help speed new discoveries to the public.”


While this was a very welcome message and encouraged many companies to
begin to become more interested in CDISC standards, it hardly produced a
sudden groundswell in the adoption of CDISC data standards among