CDISC Leadership

I hope you will indulge me to share a brief story. Earlier this month, I was at a conference and a long-time CDISC volunteer from a member company introduced me to her colleague. She said, “This is David Bobbitt. He’s behind all these changes at CDISC.” Her colleague hugged me in greeting, which made me think she’s a fan of the changes she’s been experiencing.

It has been a busy quarter at CDISC with not a small number of changes. Our amazing Data Science team led by Dr. Sam Hume launched CDISC Library, the newly christened successor to CDISC SHARE, which includes a brand new API. You can read more about what CDISC Library and the API can do for you and your utilization of CDISC standards in this newsletter.

Featured Articles

What is the CDISC 360 Project?

CDISC 360 seeks to implement standards as linked metadata with a conceptual foundation providing the additional semantics needed to support (1) expression of the full meaning of clinical data through its expressed relationships to other clinical data; (2) a single, unified implementation of the CDISC Foundational Standards; and (3) metadata-driven automation across the clinical research data lifecycle.

CDISC is pleased to announce CDISC Library, our standards metadata repository, will be available to all members 10 April. We opened access to Platinum Members in mid-February and are happy to deliver access to our Gold Members in a few weeks.

Attend any healthcare conference and you are unlikely to miss enthusiastic, well informed (ok along with some less informed, but know the buzzwords - looking at you blockchain) discussions on innovation and technology and how we can ultimately transform healthcare. That’s before you meet a multitude of pretty impressive new start-ups bringing new concepts and when you are done with all that you can then load up the latest new apps.

 

CDISC is growing! We invite you to contribute your skills and expertise by joining our team. We are always looking for people who share our passion for bringing clarity to data.

If you think you have the right skills and mindset, we want to hear from you!

Angelo Tinazzi

Director, Standards, Systems, CDISC Consulting, Statistical Programming
Cytel Inc

How long have you been volunteering at CDISC?

Six years. I joined the CDISC China Coordinating Committee (C3C) in 2012

 

The Standards Community lost a tireless advocate with the recent passing of former CDISC Board Chair and contributor, Ed Helton. CDISC Co-founder and President Emeritus, Dr. Rebecca Kush, penned a thoughtful and caring remembrance of his life and work.

Standard Updates

CDISC Foundational Standards focus on the core principles for defining data standards and include models, domains and specifications for data representation. Foundational Standards released this quarter:

ADaM Conformance Rules v2.0

Version 2.0 of ADaM Conformance Rules is composed of 350+ rules, which can implemented with software to test rules defined in the ADaM Implementation Guide v1.0, ADaM Implementation Guide v1.1, and the ADaM Structure for Occurrence Data v1.0.

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 relies on the subject matter expertise of volunteers to create our data standards. Currently three teams are looking for volunteers. We invite you to join this effort.

Membership Update

 

 

 

 

Q1 NEW MEMBERS

Platinum Members

  • DT & SanoMedics – South Korea
  • Galapagos NV - Belgium
  • Population Health Research Institute - Canada
  • PPC Group - China

Gold Members

As part of CDISC Membership benefits, each Platinum Member organization can receive two complimentary seats and each Gold Member organization can receive one complimentary seat to the ½-day CDISC Library Workshop (9.00am – 12.00pm, Tuesday 7 May, 2019) during our Europe Interchange. Seats are limited!

CDISC Around the Globe

The European Interchange Conference is coming closer. I think we have a very exciting program where we would like to say thank you to the CDISC community sending us so many great abstracts. This lead us to a wonderful program with presenters from the Regulatory Agencies, the CDISC organization and our members. Beside, like last year, we will also have a poster area with many posters showing industry trends and present CDISC topics.

Our last event in Geneva (4th December 2018), sponsored by SAS and Excelya was a great success thanks to a quality content provided by many CDISC well known faces!  Please visit the French User Group Update in the CDISC Q4 Newsletter for details.

The CDISC German User Network held our first face-to-face meeting for 2019 on 6 March in Berlin-Charlottenburg. PAREXEL International hosted the community. Half of the participants met the night before for dinner in the Russian restaurant Samowar.

The 6th Annual CDISC Italian User Network was held at the SAS office in Milan 22nd February 2019. In collaboration with IBiG, the Italian Association of Biostatisticians, and sponsored by SAS and Cytel, the event enjoyed record attendance!  As active members of the Italian CDISC User Network as well as the CDISC European Coordinating Committee, Angelo Tinazzi (Cytel) and I chaired the event and presented the topic "What’s new at 360°".

In the Nordic Region, we have many companies who are members of CDISC and it seems logical that we now form a User Group to share our good practice and discuss how we can help one another to improve our practices.

The CDISC UK Network is excited to announce two great presentations for our spring ‘CDISC Operational Implementation’ themed webinar on 3 Apr at 14:00 BST.

    CDISC standards have been adopted and used in more than 90 countries. In recent years, more and more professionals in China are applying CDISC standards in their clinical studies. To acquaint CDISC users in China with recent updates of CDISC standards, a seminar was conducted by the Shanghai CDISC User Group on 7 Dec 2018.

    2019 CDISC Japan Interchange

    The Japan CDISC Committee (J3C) has been hard at work preparing for the 2019 CDISC Japan Interchange in Tokyo. The conference will be held 10-12 July at the Ito International Research Center at Tokyo University, with the Academic Workshop taking place 10 July, and the Main Conference from 11-12 July. For the first time, we are planning a two-track program.

    The CDISC Japanese User Group (CJUG) held a our annual workshop 7 March at the APRICO conference center with 60 people in attendance.  

    CDISC Education

    Greater Clarity Starts with CDISC Education

    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.

    CDISC is pleased to announce Japanese-language versions of Introductory CDASH, Define-XML and SDTM are now available in our online learning system. These trainings, along with the previously published Introduction to Controlled Terminology are the only Japanese-language online trainings authorized by CDISC.

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

    Upcoming Events

    Register now for the CDISC Europe Interchange.

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    In the News

    Austin, TX – 17 January 2019 – CDISC today announced three new members have joined its Board of Directors. Dr. Pandu Kulkarni, Dr. Hiroshi Masumoto, and Dr. Zhengqing Li each began serving a three-year term at the beginning of the year.