CDISC Leadership

 

We begin the final quarter of the year with a great deal of momentum. This summer, I was able to attend the public launch event for www.Vivli.org, a new data sharing platform, supported by CDISC partners and members including AbbVie, Pfizer, Bill and Melinda Gates Foundation, Duke University, Critical Path Institute, and the Helmsley Charitable Trust. It is exciting to see the advancement of data sharing, which is undergirded and supported by standards.  Former CDISC Board Chair, Dr. Frank Rockhold of Duke University, reminded all in attendance that, though CDISC has only been around for 20 years, it has made such a huge impact.  Thank you for being part of, and building, clinical data standards that are truly changing the world for the better. 

Featured Articles

CDISC is growing! We invite you to contribute your skills and expertise by joining our team: we are hiring junior and senior Standards Developers for CDASH, SDTM, and ADaM as well as Project Managers in staff and contract positions.

Jordan Li

Biomedical/Clinical Research Information Specialist
Enterprise Vocabular Services (EVS), National Cancer Institute Contractor

 

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 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.

CDISC launched the initial version of CDISC SHARE v2.0 at the beginning of September, and will be adding new content and features prior to the end of the year in support of an early 2019 public release.

CDISC SHARE v2.0 includes content migrated from CDISC SHARE v1.0 for SDTM, SEND, ADaM and CDASH with additional levels of granularity not available in v1.0. The CDISC SHARE v2.0 release in early 2019 also includes new standards publications not available in CDISC SHARE v1.0, with additional standards content scheduled for loading post-release as it becomes available, including provisional standards, rules, questionnaires, examples, external standards mappings and biomedical concepts.

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. 

Membership Update

It is hard to believe that there are just three months to the end of 2018. This is a good time to remind all our valued members to take advantage of the Membership Benefits available to all employees of our member organizations. Use your 20% discount (Gold Members) or 40% discount (Platinum Members) to attend our Education Courses and the Main Conference at the upcoming 2018 US Interchange .

Please remember that member organizations can also enjoy a credit of $1,000 to $2,500 annually to take CDISC Online Courses. Do take advantage of this credit before the end of the year.

We are happy to announce our new members for Q3 2018 and recognize long-standing members of CDISC. We are grateful for your support.

 

CDISC Alliances

As one of our strategic goals, CDISC strives to understand how our standards can be flexible for all types of data being collected in clinical research.

Our PhUSE partners are currently conducting a two-question survey to evaluate data standardization in Observational Studies; they would love input from our CDISC global commuity.

CDISC Around the Globe

The CDISC China Interchange was held 6-7 September, 2018 in Beijing. The conference attracted record-high attendance and was very well represented by Pharma, CROs, Biotech, Technology Services Providers and others in the Life Sciences industry. Simultaneous interpretation between Chinese and English was available throughout the two-day conference. Topics presented included Regulatory Updates, CDISC Standards Development, Use Cases, Process, Efficiencies and Tools, Therapeutic Areas and much more.

CDISC Japan Interchange

The Japan CDISC Committee (J3C) organized a very successful CDISC Japan Interchange, which took place 9 – 11 July at the Ito International Research Center at Tokyo University. The first day featured a special workshop on using CDISC standards in academia. PMDA and AMED provided regulatory expectations and offered helpful approaches for implementing the standards. We are encouraged that the use of CDISC standards is gaining momentum in Japanese academia; proactive activities of CDISC standards are important for the implementation.

The GUF Board is pleased to announce we received extremely positive and encouraging feedback from participants who attended our User Group in May. The last Board committee face-to-face meeting took place in Paris at the beginning of July. The purpose of this meeting was to renew main Board positions as our previous president Xavier Gobert, after many years of service, decided to step down. We want to take this opportunity to thank Xavier for his dedication and for leading the group toward so many successes over the years. 

On September 25 AbbVie Deutschland hosted the 2nd face-to-face meeting in 2018. 45 participants joined the meeting, which took place on their campus in Ludwigshafen. The night before the sponsor organized an excellent dinner at the Neckar river side.

As usual, the German User Network sought the participants’ active discussion in lieu of presentations.

The India User Group invites all interested people in participating in the exchange and discussion about CDISC Standards to join us.  The newly formed group has 50 people so far in the Mumbai and Pune regions from organizations such as Syneos Health, IQVIA, TCS, Sciformix and Novartis. Our inaugural meeting is planned in mid-October and will be followed by publication of articles along with holding webinars and monthly teleconferences.

 

2018 CDISC Japan Interchange was another big success. Many thanks to the volunteers and sponsors who assisted in the well-run operations.

The CJUG SDTM team held July meeting at the University of Tokyo with Dr. Maruyama from Keio University hospital presenting. Two sub-teams comprise CJUG SDTM Ducks (beginners) and Turtles (experts) and include members from Japan and abroad. The Ducks designed a mock study and created SDTM datasets, working and discussing to improve their know-how on to develop higher-quality SDTM datasets. The Turtles discussed various SDTM topics, developing tools to work with CDISC Standards.

The CDISC UK Network held a successful face-to-face meeting in London in July. We had a great range of presentations and excellent discussion, thanks to all of our speakers and attendees. Slides are available here: https://wiki.cdisc.org/display/GBRUG/2018+Face+to+Face.

We will hold our next Webinar on 31st October at 13:00 GMT. Kelly Mewes and Bhupendra Mistry from Roche will repeat their presentation ‘R U Submission Savvy?’, and will be joined by Marianne Carames from Novo Nordisk, looking into ‘Is it Possible to Make a Global CDISC Submission?’.

    CDISC Education

    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.

    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.  

    Upcoming Events

    CDISC partners with a variety of organizations to further the global adoption of standards. We will be presenting at various conferences worldwide this fall. Join us!

    In the News