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First Quarter 2018

Featured Articles

The 7th Annual PhUSE CSS meeting took place 4 – 6 March at the Silver Spring Civic Center with over 270 stakeholders from various industry backgrounds were in attendance. It is inspiring to see the PhUSE volunteer working model mature and the subsequent deliverables represent a significant resource to the industry and worldwide regulators, including the FDA. 

CDISC staff and volunteers enjoyed a busy week, gathering in Silver Spring, Maryland. We began the week at the PhUSE Computational Science Symposium and finished it out attending the CDISC Working Group Meeting to work on CDISC standards development and implementation topics. CDISC Working Group Meetings take place twice annually with CDISC Staff, volunteer team leaders and members focusing three full days on the core development of the Foundational standards and cross-team alignment projects.

CDISC staff and volunteers enjoyed a much-deserved time to relax at McGinty's Pub at the end of the day.

The CDISC Implementation Primer project, sponsored by PhUSE and CDISC and  run by Scott Bahlavooni and Peter Van Reusel, kicked off during the 7th Annual PhUSE CSS meeting.  The goal of project is to develop a set of resources to guide industry newcomers and learners in using and implementing CDISC.  

In an effort to improve user experience on our website for those new to CDISC as well as returning visitors, we have added four new pages:

New to CDISC - We recently hosted a webinar for stakeholders new to navigating CDISC standards and the CDISC website.; we will be posting new webinars quarterly

How long have you been volunteering at CDISC?

I have been volunteering at CDISC since around 2011. I started by working with CDASH teams.

What should someone new to CDISC know about the PGx standard and why was it important to you to lead this team?

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.

Study Data Tabulation Model v1.6 supports Standard for Exchange of Nonclinical Data Implementation Guide: Development and Reproductive Toxicology (SENDIG-DART) v1.1 and includes additional variables related to DART animal studies.  SDTM v1.6 is the second standard to be published in HTML format, which expedites delivery of the standard to implementers and can be viewed in any standard browser.

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 API described below.

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. 

Since starting work on ODMv2 last year the CDISC Data Exchange Standards Team, formerly known as the XML Technologies Team, has made substantial progress towards completing the backlog tasks and updates planned for ODMv2. Much of this work is progressing concurrently, creating a broad set of ongoing discussions.

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’s VP of Strategy and Innovation, Dr. Lauren Becnel presented the workshop "AI-assisted data and knowledge acquisition for biomedical researchers" 7-8 March at the European Molecular Biology Laboratory-European Bioinformatics Institute (EMBL-EBI) on the Wellcome Genome Campus in Hinxton, UK. 

Sam Hume, CDISC's Head of Data Exchange Technologies and Wayne Kubick, CTO, HL7 International teamed up to present CDISC & HL7 Moving the Clinical Research Agenda Forward at Healthcare Information and Management Systems Society (HIMSS) on 8 March 2018.

CDISC's Interim Chief Standards Officer and VP of Education, Shannon Labout, will be present at the Society of Clinical Data Management 2018 EMEA Leadership Forum; Ms. Labout is Board Chair of SCDM.

CDISC Around the Globe

We are pleased to announce two new CDISC User Networks have begun in the Asia Pacific region - one in Mumbai, India, another in Melbourne, Australia. If you are interested in learning more about either of these User Networks, please contact membership@cdisc.org

Nominations are now open for new members of the China C3C. We invite you to submit nominations; self nominatioins is also welcome.

We looking forward to your joining us at the upcoming Europe Interchange  23 - 27 April. The conference features keynote speaker, Dr. Martin Gibson, Chief Executive Officer, Northwest EHealth Director, NIHR Clinical Research for Greater Manchester as well as regulatory presentations from Dr. Alison Cave (EMA), Dr. Ron Fitzmartin (FDA),  Dr. Lisa Lin (FDA), and Dr. Yuki Ando (PMDA). The program inlcudes three tracks of informative content and interactive sessions presented by experts in the fields of Data Standardization Development and Implementation.

The next CDISC French User Group meeting will be held in Boulogne-Billancourt (near Paris) on the 29th of May. This meeting will bring together over 100 experts to discuss such topics as the CDISC Standard SEND and metadata repositories as well as using preclinical and clinical data in AI and Medical Internet of Things (IoT).

The 26th meeting of the German Speaking CDISC User Network in Heidelberg, hosted by HMS Analytical Software, brought together, once again, the lively community of SDTM and ADaM users throughout Germany, Austria and Switzerland. The group has definitely increased, with 47 colleagues from various Pharma companies and CROs in attendance.

The Italian CDISC User Group continues to hold teleconferences quarterly and there are tentative plans to hold a face-to-to meeting in Milan14-18 May. During that week, CDISC public training will take place in Milan.

 

 

The CDISC Japan User Group (CJUG) SDTM team is working not only to expand the team members’ knowledge of CDISC and SDTM, but also to accumulate and exchange their implementation know-how. The team currently has about 180 members who share their experiences with fellow members through presentations, allowing members to deepen their knowledge of CDISC to effectively apply CDISC standards and contribute to the medical care development.

The CDISC UK Network are delighted to welcome Jenny Griffiths back as co-chair, and Bhupendra Mistry as a committee member. Huge thanks to Will Stevens for his excellent work as our co-chair to progress the group, share his experiences from academic research and host our most recent face to face meeting at The University of Oxford. All the best Will!

CDISC Education

Join us for one (or more) of 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.  

CDISC is pleased to announce our Asia Webinar Series to accommodate stakeholders throughout Asia. These webinars are delivered during convenient times as well as in languages, such as Mandarin and Japanese. The next edition in the series is CDASH and SDTM: Why Do We Need Both Standards?, which will be presented in Mandarin. 

Upcoming Events

Join us at one of our 2018 Interchanges!

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

In the News

Austin, TX18 January 2018– The Clinical Data Interchange Standards Consortium (CDISC) today announced Chris Decker and Pam Howard have joined its Board of Directors to serve three-year terms, which began 1 January 2018.

Austin, TX – 28 MAR 2018 – The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce it has been awarded a grant in the amount of $1,000,000 by The Leona M. and Harry B. Helmsley Charitable Trust to develop Type 1 Diabetes (T1D)-related data standards.