CDISC Leadership

I’ve always said good people are drawn to CDISC because of their desire to bring clarity to the data and impact global health. People are our greatest asset. The CDISC staff and our global community of members, volunteers and stakeholders have indeed done, and will continue to do, great things.

Last month CDISC released SDTM v1.7 and SDTMIG v3.3. Thank you to all CDISC volunteers, staff, and our amazing community members who contributed to this significant upgrade whether through working on the update directly or through reviewing and commenting.

 

Featured Articles

During the course of my career, I have been blessed with interesting and challenging opportunities and have had the privilege of meeting and collaborating with fascinating people. Data standards have been a passion of mine and I’ve always wanted to share this passion.

Ruiling Peng

CEO
Beijing Improve-Quality Technology, Co., Ltd.

How long have you been volunteering at CDISC?

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

 

Joining the CDISC Board of Directors in 2015 was an easy decision. CDISC is an organization dedicated to the development and deployment of standards that are essential for use in clinical research to enable the accessibility, interoperability and reusability of data. CDISC’s lean operating structure, strong volunteer base and value proposition appealed to me as we all, in this industry, strive for greater efficiency, more discoveries, and accelerated time-to-market for new drugs.

CDISC Interchanges have become one of my favorite conferences to attend.  The Interchanges have always been enjoyable, providing opportunities to gain and share information and ideas, network with experts, meet and connect with people, and enjoy good food.

Standard Updates

Therapeutic Area (TA) Standards extend existing CDISC standard metadata to include disease-specific metadata, examples and guidance on implementing standards for a variety of uses, including global regulatory submissions. To date, CDISC has developed TA standards for over 30 indications.

This year’s Glossary update includes a more robust and frequently used request process for new terms since Glossary activity is better integrated into Controlled Terminology to support the exchange of digital information. The Glossary seeks to eliminate semantic confusion in human information exchange and disambiguate the meaning of terms, acronyms, abbreviations, and initials used in Foundational Standards developed.

Controlled Terminology is the set of codelists and valid values used with data items within CDISC-defined datasets. Controlled Terminology provides the values required for submission to FDA and PMDA in CDISC-compliant datasets. Controlled Terminology does not tell you WHAT to collect; it tells you IF you collected a particular data item, how you should submit it in your electronic dataset.

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 continues to develop new tools and standards that support clinical and translational data science. In Q1 2019, we will release CDISC SHARE v2.0, a metadata repository with an application programming interface (API) and standards development tools. CDISC SHARE v2.0 provides a new API, an expanded metadata model, and new standards content.

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.

Membership Update

 

 

 

 

 

 

NEW MEMBERS (October - November)

Platinum Member

  • Ashermed Healthcare Communications Co., Ltd. - China
  • LLX Solutions - USA
  • Massachusetts General Hospital – CIB – USA

Gold Members

CDISC Around the Globe

The call for abstracts for the 2019 CDISC Interchange in Amsterdam is out. We hope to receive a lot of very good abstracts. Abstract submission deadline is 11 January. If you haven’t sent your abstract, please visit the Submission Page to investigate if you have a topic you want to present (or create a poster), which would interest to the CDISC community.

The second CDISC French-Speaking User Group (GUF) event of the year was held in Geneva 4 December 2018, sponsored by SAS and Excelya at the great Warwick Hotel. There were around 60 attendees, an engaged audience reflecting the commitment of CDISC community to continue to pave the way forward with standards.

The CDISC German User Network will hold our next face-to-face meeting 6 March 2019 at the PAREXEL office in Berlin. We continue to  hold  teleconference calls the third Friday of every month from 10:00 - 11:00 am. Please visit our Wiki page for more information.

The next CDISC Italian User Network event will take place 22 February 2019 in Milan. The event's theme is “What’s New at 360°”. We are currently in the process of selecting speakers and invite CDISC users to submit proposals to Silvia Faini (silvia.faini@livanova.com) or me (angelo.tinazzi@cytel.com). Presentations can be deliverd in Italian (preferred) or English.

The CDISC UK Network held a successful and well-attended webinar on 31st October 2018. Huge thanks to our speakers Kelly Mewes and Bhupendra Mistry from Roche who repeated their London presentation ‘R U Submission Savvy?’, and were joined by Marianne Carames from Novo Nordisk, who looked into ‘Is it Possible to Make a Global CDISC Submission?’. Slides are available here: 2018 October Webinar

    The CDISC Japan User Group (CJUG) comprises six teams, which are actively in deep discussion, researching and exchanging information.

    CDISC Education

    CDISC is pleased to announce our new online learning platform is now available. You can access the system on our website by logging in to your account and visiting the online learning platform to begin learning. If you don’t have an account, create one here.  This account will also allow you to download standards and access the Members Only Area, if your organization is a CDISC member. Membership discounts are automatically applied.

    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.

    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 – 12 OCTOBER 2018 – CDISC wrapped up its 15th annual U.S. conference in Bethesda, MD, where attendees were the first to hear about a number of new initiatives as well as participate in active discussions with regulators including representatives of U.S. FDA and Japan PMDA. CDISC Interchanges are global events held annually on three continents with hundreds of attendees gathering to network, share their expertise, best practices, and lessons learned about implementing CDISC standards to bring clarity to clinical research data.

    TUCSON, Ariz., NEW YORK and AUSTIN, Texas, November 1, 2018 — The Huntington’s Disease Regulatory Science Consortium (HD-RSC), launched in March 2018 by the Critical Path Institute (C-Path) and CHDI Foundation, today, along with the Clinical Data Interchange Standards Consortium (CDISC), announce the open availability of a newly developed Huntington’s Disease Therapeutic Area User Guide (TAUG-HD). The guide has been developed to describe the most broadly utilized clinical concepts for data acquisition and analysis in Huntington’s disease (HD) clinical studies using the CDISC standard format. The user guide defines parameters for data collection and allows datasets from different sources to be compared or combined for sharing and analysis.

     

    AUSTIN, Texas 12 Dec 2018 – CDISC and Cohen Veterans Bioscience are pleased to announce the publication of a new Therapeutic Area (TA) Standard for Post Traumatic Stress Disorder released in the form of a User Guide for data managers, statisticians, programmers and study managers.