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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

29 Aug 2013

What Did the CDISC Teams Accomplish during the Recent CDISC INTRAchange in Silver Spring, MD?


The CDISC INTRAchange is an opportunity for CDISC team members to meet and discuss their CDISC-related work, including current and future tasks, and it provides a special opportunity for cross-team meetings to ensure an understanding of how one team’s activities relate to others. Team members are volunteers who dedicate time from their busy schedules to develop CDISC standards for the purpose of achieving the CDISC mission to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. The CDISC teams are essential to the progress of CDISC and to the process of developing consensus-based global standards. All of the CDISC teams met at the INTRAchange during this 3-day period at the end of July and 1 August. To find out more about the specific CDISC Teams and deliverables, please see the CDISC Annual Report 2012.


The event started on the morning of 30 July with the opening plenary by Wayne Kubick, CDISC CTO, who expressed his deep appreciation to the CDISC volunteers for their hard work and essential role in achieving the CDISC mission. He also presented the CDISC Technical Roadmap and updated all attendees. Dr. Ron Fitzmartin of FDA then presented the FDA Standards Strategy. The slides from these presentations can be made available upon request.












24 Jul 2013

I did not attend many sessions at the DIA meeting because, as many attendees, I was busy meeting new people interested in CDISC and reconnecting with many old friends. I did, however, chair one session – on CFAST: Coalition For Accelerating Standards and Therapies and I attended the subsequent session chaired by Dr. Steve Wilson on the FDA Data Standards Strategy. This was a very informative session with three speakers and a ‘commenter’: Dr. Ron Fitzmartin (FDA), Bron Kisler (CDISC), Mitra Rocca (FDA) and Michael Brennan (J&J).


Dr. Fitzmartin spoke of FDASIA, the FDA Safety and Innovation Act. Specifically, Section 1136 allows FDA to require standardized eSubmissions. Also, it reauthorizes the fifth instance of the Prescription Drug User Fee Act (PDUFA V). The schedule for phasing in these eSubmission requirements is specified as 24 or 36 months after publication of the final guidance (time frame depending on the type of submission). Section XII under the PDUFA Goals states the following:


  • Clinical Terminology Standards: Using a public process that allows for stakeholder input, FDA shall develop standardized clinical data terminology through open standards organizations (i.e., CDISC)…


Also, FDA is to publish a proposed project plan for stakeholder review and comment by 30 June 2013. Dr. Fitzmartin stated that this TA Standards Project Plan is in Clearance at FDA, along with the eStudy Data Guidance and an eSource Guidance. He provided further specifics around the FDA Path to Required Study Data Standards.

24 Jul 2013

We had the pleasure of meeting with a number of wonderful individuals in Europe in June. The theme from our perspective was CDISC, of course, but there were many threads of conversation that wove together a lovely tapestry of memory from this particular trip and, in turn, we feel was extremely helpful to CDISC.


The trip began in Paris, meeting with Dr. Michel Goldman and Dr. Olivier Arnaud. The topic was around the Juvenile Diabetes Research Foundation, for which Dr. Arnaud is providing scientific expertise in Europe. Dr. Goldman is an amazing individual who leads the Innovative Medicines Initiative. He had expert advice to lend during this meeting for the JDRF in Europe. CDISC has just launched a diabetes therapeutic area standards project and IMI has projects in diabetes, so a relationship is attractive to all of the organizations and the value of having standards for diabetes research is clear. On a recent call of the CFAST Scientific Advisory Committee, one attendee remarked of the data sharing initiative we were discussing: “The data are so much more valuable when they are in a common standard format”.