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Second Quarter 2018

CDISC Leadership

The clinical data standards community began the summer with some great news, Peter Van Reusel has joined CDISC as Chief Standards Officer. You can read a bit more about him in this newsletter.  Peter recently joined me at a meeting at the US FDA, and one of our FDA colleagues commented to me as the meeting started, “You don’t need to introduce Peter, we know him already!” 

Featured Articles

As CDISC’s new CSO, what will be your priorities?

My priorities are two-fold. One, we will continue to support, maintain and improve the current standards; equally important, we will ensure the standards will evolve to meet the needs of the future.

The continued focus for CDISC will be stability and usability. We will safeguard the global investment in our data standards to create a stable environment where our stakeholders will continue to use and benefit from the standards. 

As part of our vision for CDISC 2.0, we have tapped into the global genius from the clinical data standards community to create a Blue Ribbon Commission.  The Blue Ribbon Commission will advise the CDISC Board and me on what changes we must prepare for to serve clinical data standards needs now and in the coming decade. We will actively engage our stakeholders in gathering information and needs as well as in communicating the findings of the Blue Ribbon Commission broadly.

The FDA Honor Award for Group Recognition (Crosscutting Project) was given to the FDA PhUSE Study Data Standardization Plan Team for creating, reviewing and institutionalizing a Study Data Standardization Plan led by CDISC's Senior Director of Standards Development, Lou Ann Kramer, who facilitated the non-clinical contribution to the Study Data Standardization Plan.

Hidetoshi Misawa

Group Lead, Program Data Management Group, Japan at Pfizer

Hidetoshi chairs the Japan CDISC Coordinating Committee (J3C).

As an interested party of CDISC, you have the opportunity to nominate candidates for the CDISC Board of Directors. There will be up to three Board seats opening up with terms beginning 1 January 2019.

Standard Updates

CDISC invites interested stakeholders to submit comments on the following standards available for public review. We rely on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all.

CDISC Controlled Terminology is the set of CDISC-developed or CDISC-adopted standard expressions (values) used with data items within CDISC-defined datasets. CDISC, in collaboration with the National Cancer Institute's Enterprise Vocabulary Services (EVS), supports the controlled terminology needs of CDISC Foundational and Therapeutic Area Standards. 

CDISC SHARE  is a curated resource that makes machine-readable core standards content available in a variety of formats through CDISC SHARE Exports or the CDISC SHARE API described below.

Membership Update

We are happy to announce our new members for Q1 2018 and recognize long-standing members of CDISC. We are grateful for your support.

 

 

CDISC Alliances

CDISC staff enjoyed informative sessions, meeting with colleagues, and learning Transformative Current and Emerging Best Practices at PhUSE Connect in Raleigh, North Carolina.

 

CDISC Around the Globe

The inaugural meeting of the Australia CDISC User Group was held in Melbourne on Friday 8th June.  In attendance were Ross and Jennie Anderson from Evado, Siang Tia from Seqirus, Emma Callegari and Gareth Jones from PMCI.

The European CDISC Committee (E3C) organized a very successful CDISC Interchange, which took place in Berlin. More than 300 participants met on 25 and 26 April at the Titanic Chausse Hotel for this two-day conference. 

The CDISC French-Speaking User Group (GUF) first event of the year was held in Boulogne-Billancourt (near Paris), on 29th May 2018 and took place in the theater room of Espace Palissy, thanks to the help of the AFCROs (French Association of CROs). The GUF Board would like to thank the Sponsors who helped us make this conference a success: Medidata, PointCross, Cognizant and XClinical.

About 100 people attended the conference, including a significant number of newcomers. We were pleased CDISC members were present during the event.  Thank you to Stijn Rogiers (E3C) and congratulations to Peter Van Reusel who was recently named CDISC’s Chief Standards Officer. We offer our best wishes of success to Peter regarding this new position.

The German User Network invites all interested people to participate in the exchange and discussion about CDISC Standards. Members mainly consist of contributors from Germany, Austria and Switzerland; other German-speaking contributors are welcome to join our discussions. The German User Network is officially referred to as “CDISC DACH User Network”; DACH stands for Deutschland, Austria, Confoederatio Helvetica (official Latin name for Switzerland).

With mounting clinical research skills and passion in India, there was quite a need to create a CDISC User Group in India to serve as a support system to connect and keep up with the fast-paced industry.

It’s a real delight to announce this news in the Q2 newsletter!

Core committee: Dr. Prashant Kirkire (IQVIA) and Sandeep Sawant (Syneos Health) (to be extended with the plan of creating sub-teams)

The J3C has been hard at work preparing for another informative Interchange in Tokyo. The conference will be held 9-11 July at the Ito International Research Center at Tokyo University, with the “Use of CDISC Standards in Academia” Workshop on 9 July, and the Main Conference from 10-11 July. The theme of the conference is “Ensuring and Improving Clinical Trial Quality Management Systems through Global Standards.”

Huge thanks to Sandra, Tom and Janet for their presentations at the CDISC UK Network webinar on 15 May. Presentations are available on our Wiki page.

PhUSE Single Day Event

For the second time in a year, CDISC Japan User Group (CJUG) SDTM team held a conference with PhUSE Japan on 11 May. The aim of the joint event both organizations working together to further contribute to medicine and medical drug development.

CDISC Education

Join us for our upcoming webinars, which address industry hot topics, along best practices and challenges around implementing the standards, allowing attendees to learn from the CDISC community of experts.  

Learn CDISC from CDISC!

Our  Public Training courses provide expert-led training for individuals of all experience levels. Courses range from 1/2-2 days. Participants can choose to register for one or all courses offered.

Upcoming Events

CDISC partners with a variety of organizations to further the global adoption of standards. 

In the News

Austin, TX – 30 MAY 2018 – CDISC is pleased to announce long-time standards advocate, skilled instructor and current European Liaison, Peter Van Reusel, as the organization’s Chief Standards Officer.