Second Quarter 2019

CDISC Leadership

Letter from President and CEO

David R. Bobbitt, MSc, MBA, President and CEO, CDISC

Recently my spouse and I saw the live-movie version of Aladdin. It’s a great story, updating the Disney cartoon classic. Besides the wonderful songs and dancing and the funny Genie character, the movie brings out powerful themes of friendship and service to others. When Aladdin rubs the magic lamp and gets his three wishes, the Genie advises him not to squander them on wealth, power, or fame. Instead the Genie advises that Aladdin focus on more important values: right relationships and, even, true love. I won’t give away the ending, but in the end Aladdin makes a key choice and helps a friend rather than pursue personal power. That makes all the difference, and Aladdin matures from boy to adult.

Volunteer Spotlight - Yumiko Asami

Yumiko Asami

Manager, Data Intelligence, Biostatistics & Data Management Daiichi Sankyo Co., Ltd.

Former leader of the CDISC Japan User Group (CJUG) ADaM team

How long have you been volunteering at CDISC?

For 11 years. I have been volunteering on the CDISC Japan User Group (CJUG) ADaM team since 2008, and led the team for eight years (2011-2018).

CDISC Library

Mike Hamidi, Head, Data Science, CDISC

CDISC is pleased to announce that our next CDISC Library release will be available mid-July 2019 to all members. CDISC Library is the single, trusted, authoritative source of CDISC standards metadata and represents a new way of creating, maintaining, and publishing this metadata. CDISC Library uses linked data and a REST API to deliver CDISC standards metadata to software applications that automate standards-based processes. Since CDISC Library’s release in April 2019, over 60 organizations across three continents (Asia, Europe and North America) and seven industry categories (government, academia, consulting, biotech, technology service provider, pharmaceutical, and CRO) have obtained access.

CDISC 360 has Launched

Peter Van Reusel, Chief Standards Officer, CDISC

The CDISC 360 project, introduced in the Q1 Newsletter, launched the week of 8 April 2019 with a Kick-off meeting and a Workstreams Briefing meeting for over 45 participants. CDISC 360 will run for 18 months and the first 10 agile sprints (3-4 weeks each) will cover the remainder of 2019.

Tremendous Interest in Participating

As of today, more than 60 talented individuals from 26 CDISC member companies are contributing active expertise to this important project. They are a global group from Asia, Europe, and North America. Their companies cover the spectrum we hoped, including pharmaceuticals, biotechs, CROs, technology firms, and solutions providers.

A series of collaboration tools have been provided to support workstream teams as members work remotely worldwide. These tools include shared environments for document content (Wiki), issue tracking (Jira), concept mapping (Cmap Cloud), instant messaging (Slack), and metadata management (CDISC Library). In addition, Microsoft, as a project participant, is providing its Azure platform to further support collaboration, including but not limited to support for data storage and script execution in multiple scripting languages as the project team executes the use cases.

Board of Directors Call for Nominations

Stephen Pyke, Board Member, CDISC

As an interested party of CDISC, you have the opportunity to nominate candidates for the CDISC Board of Directors. There will be up to five Board seats opening up with terms beginning 1 January 2020.

The CDISC Board of Directors is made up of approximately 12-15 members, each serving a three-year term. Board membership requires people who care about the organization, are willing to offer their time and expertise, enjoy being in a leadership role, and want to contribute to CDISC’s work to improve medical research. The Board has approximately four teleconferences per year as well as two in-person meetings per year that usually last two days. Each board member will serve on at least one Board committee: Financial, Governance or Executive.

CDISC Japan Liaison Appointed

We are pleased to announce that Yoshiteru Chiba has joined CDISC as a contractor in the newly created role of CDISC Japan Liaison. In this role, Chiba-san will serve as the formal contact person for CDISC in Japan on a daily basis. He will advise CDISC President and CEO, David R. Bobbitt, on the growth and development of CDISC standards in Japan and globally. Chiba-san will manage day-to-day relationships with key CDISC stakeholders in Japan, including members, implementers, J3C, and Japanese government entities.

Working Group Meeting

CDISC staff and volunteers gathered once again 12 - 14 June in Silver Spring, Maryland for the annual Working Group Meeting. The Working Group Meeting focuses on cross-team sessions devoted to accomplishing 2019 CDISC team goals and addressing common topics of interest among all CDISC teams. Foundational teams also devoted a full day to within team meetings to make progress upcoming team deliverables. Over 90 volunteers were in attendance to participate in face-to-face meetings with the teams they work with virtually throughout the year. They tackled a robust agenda that included such topics as SEND & SDS Team Development Principles, Redesigned Metadata Specifications & Conformance Rules,SDS & Lab/CT Updates to Lab-related Domains, Examples Collection Development, and Fundamental Definitions of CDISC Documents.

Expanding the Outreach of Therapeutic Area Standards for T1D and Crohn’s Disease

John Owen, Senior Project Manager, CDISC

With support from The Leona M. and Harry B. Helmsley Charitable Trust, CDISC is developing Therapeutic Area User Guides for Type 1 Diabetes (T1D) and Crohn’s Disease (CD). Treatments for these disease areas are available, however, exact causes of both diseases are still unknown. Helmsley supports global research in many areas of T1D and CD with the aim of improving the lives of people living with these diseases, identifying strategies to prevent onset of T1D, and to prevent as well as find a cure for CD. These CDISC projects align with the Helmsley goals to enable data sharing, cross-study comparisons and meta-analysis by standardizing clinical data, increasing efficiency in research to accelerate development of potential new therapies as well as finding new scientific links within and between disease areas.Support from Helmsley has provided access to a greater spectrum of medical researchers and key opinion leaders from academia and medical research institutions, innovative device and technology organizations, adding to the already strong CDISC community members involved in T1D and CD Research. These initiatives align with key CDISC goals and visions particularly in expanding the use of clinical data standards.

Biospecimens Team Launches, Seeks Additional Volunteers

CDISC has kicked-off a new SDS sub-team called the Biospecimens Team led by volunteers Christine Connolly and Oliver Karch of Merck. The team is responsible for futher exploring domains Biospecimen Events (BE), Biospecimen Findings (BS), and Related Specimens (RELSPEC) provisionally published in the Study Data Tabulation Model Implementation Guide for Pharmacogenomics and Pharmacogenetics (SDTMIG-PGx). These domains are used to record events, attributes, and relationships between specimens. If appropriate this team may work to further develop these domains for formal publication in the SDTMIG and/or other CDISC standards.

Submission Data Standards Team Looking for Volunteers

The Submission Data Standards (SDS) team is responsible for developing and maintaining the SDTM Implementation Guide for Human Clinical Trials (SDTMIG). We are looking for volunteers to contribute one or more of the following skills in building SDTMIG v3.4 and future versions of SDTMIG:

Modeling and Implementation
Project Management
Clinical Trial Subject Matter Expertise

Current Public Reviews

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.

Therapeutic Area Standards

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.

Membership News

Sheila Leaman, VP, Membership, Events and Asian Initiatives, CDISC

Q2 NEW MEMBERS

Platinum Members

Clinical Trial Data Services – United States
Microsoft Corporation- United States
Northwest EHealth – United Kingdom

Gold Members

Online Training Credit for CDISC Members

Is your organization taking advantage of its online training credit? All CDISC member organizations are entitled to a yearly credit for any CDISC online training. The credit amount is based on membership level:

Gold Member - Up to $1,000 credit of Online Courses

Platinum Member - Up to $2,500 credit of Online Courses

Chinese CDISC Coordinating Committee

Guiyu Zhao, Senior Director, Medical Data Science, Hua Medicines, Inc

The Chinese CDISC Coordinating Committee (C3C) hosted CDISC public training from 22 - 26 Apr at the offices of Gold Member, Taimei, in Shanghai. Courses included CDASH, SDTM, ADaM, ODM and Define-XML. CDISC certificated instructors included Lily Zhao, Zhijun Wei, Ruiling Peng, and Yanli Chang who delivered popular lectures, which attracted nearly 60 local professionals in total.

Japanese CDISC Coordinating Committee

Hidetoshi Misawa, Pfizer

Members of the Japanese CDISC Coordinating Committee

We would like to welcome our new members who respresent various industry organizations and expertise and thank re-elected members for their willingness and enthusiasm to support CDISC.

European CDISC Coordinating Committee

Éanna Kiely, CDISC Consultant, ClinBuild

Conference themes included CDISC 360 and CDISC Standards End to End, each with a dedicated track. CDISC CSO Peter Van Reusel delivered an overview of the CDISC 360 project. CDISC’s VP of Data Science, Dr. Sam Hume took us through the CDISC Library and planned updates to ODM 2.0 and how these initiatives contribute to the CDISC 360. Frederik Malfait (Nurocor Inc) closed out the track, taking us through linked data, the technology behind CDISC 360. We also enjoyed a dedicated track to CDISC Standards End to End with a presentation on implementation projects and tools.

Bay Area User Network

John Brega, Pharmaceutical Data Standards Implementation Consultant, PharmaStat LLC

After two quiet years, the Bay Area CDISC User Network met again in April. Thanks again to all who participated! We had about 250 attendees, with 110 at the Conference Center and 140 more on the webinar. The webinar recording covers the entire meeting; if you click SHOW MORE at the bottom of the web page you’ll see the sequence of presentations with a start time for each. Click a start time to go directly to that presentation, or watch the entire recording!

Japan User Group

Yoshiteru Chiba, Head of CDISC Japan User Group

The monthly CJUG-SDTM meeting took place 10 May at the NTT DATA Mathematical Systems Inc. Seminar Room. We welcomed new members Habu, Toshiaki (Taiho Pharmaceutical CO.,LTD.) Mihara, Tomoko (Osaka University Hospital).

Attendees heard many informative presentations from our members including "Reconcilation between Define.XML and aCRF" “Akiba”-san presented method and purpose to reconcile between Define.XML and aCRF; "Activity Report on define.xml" “Muraoka”-san shared the experience and issue that has been accumulated through these activities with define.xml sub-team "Activity Report on Study Data Reviewer's Guide" “Matsunaga”-san shared the experience and issue that has been accumulated through these activities with Study Data Reviewer's Guide sub-team.　　

French User Group

Jeremy Mambrini, CDISC Standardization Project Leader, Pierre Fabre

The CDISC French User Group (GUF) held our first event of the year 24^th June at the Espace Landowski in Boulogne-Billancourt (Paris area). A big thank you to the French Association of CROs – AFCROs for their support with this! The GUF board would like to thank the sponsors who helped making this conference a success: Ividata Life Sciences, Soladis Group and Zifo RnD Solutions.

With about 130 attendees, including a significant number of newcomers (~35%), the conference was a wonderful day of sharing. According to feedback received, participants enjoyed the high quality of presentations.

We were very pleased to have CDISC Chief Standards Officer, Peter Van Reusel, attend the event. Peter shared the Blue Ribbon Commission Insights and provided an update on what’s new at CDISC. Having Peter with us was also an opportunity to receive a fresh update on CDISC 360 project.

Italian User Network

Angelo Tinazzi, Senior Director, Standards, Systems, CDISC Consulting, Statistical Programming , Cytel

A good number of Italian Users participated to the last EU CDISC Interchange in Amsterdam last may (see the picture below). This was the highest among all the EU CDISC Interchanges. During the last teleconference last June 19^th the participants discussed some of the topics from EU CDISC Interchange. The call for proposals for the 7^th Italian CDISC UN that will take place early 2020 is open.

German User Network

Kurt Hellstern, Co-owner, Hands-on, GmbH

The German-speaking User Network continues to meet for monthly teleconferences every third Friday. The dial-in information is sent out via the network’s mail list. You can sign up for our mail list on our Wiki page.

Upcoming face-to-face meeting: 25th September 2019 at Clinipace GmbH (formerly Accovion GmbH) in Eschborn near Frankfurt.

UK User Network

Mike Collinson, Life Sciences Architect, Oracle

The CDISC UK Network is delighted to announce our face-to-face meeting will take place in London on 3rd September. Come along to hear exciting news about the CDISC 360 project from CDISC CSO Peter Van Reusel, updates from the CDISC Europe Interchange and real-life implementation example presentations from our members.

We've Updated Our Courses!

Over the past year, CDISC has worked with our authorized instructors and standards experts to re-develop and update the following classroom courses:

Public Courses

Saad Yousef, Senior Manager, Education, CDISC

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.

Online Learning

John Ezzell, Head of Education Development, CDISC

In Q2 2019, CDISC updated all of our online courses. These courses take advantage of our new learning system’s interactive tools and easy-to-use learner portal. In addition to these updates, three new online courses have been published this quarter, which focus on Submission Datasets in Define-XML, Controlled Terminology Metadata, and BDS Concepts in ADaM Datasets. Visit our online learning system to learn more.

Upcoming Webinars

Bernard Klinke, Education and Events Coordinator, 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.

CDISC Interchanges

Register now for our Interchanges in Asia.

Japan Interchange: Only Two Weeks Until Conference

See our expanded conference program - 6 Regulatory Speakers and Two Tracks!
Last booths available – broaden your outreach as a valued exhibitor
Register Today

Partner 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!

CDISC, C-Path Release Therapeutic Area Standard to Drive Research Forward for Clostridium Difficile Associated Diarrhea

AUSTIN, TX and TUCSON, AZ – 02 May 2019 — CDISC and The Critical Path Institute (C-Path) are pleased to announce the release of a global Therapeutic Area Standard, which describes how to use CDISC standards to represent data in research studies pertaining to Clostridium difficile associated diarrhea (CDAD). The standard, released in the form of a User Guide for data managers, statisticians, programmers and study managers, is freely available on the CDISC website. CDISC Therapeutic Area User Guides (TAUG) provide examples and guidance on implementing CDISC standards to drive operational efficiencies within the organizations that use them, expedite the regulatory review process and reduce time to market.

CDISC at PharmaSUG

It was wonderful to see everyone at PharmaSUG! Thanks for stopping by and saying hello.

CDISC Leadership

Featured Articles

Yumiko Asami

Manager, Data Intelligence, Biostatistics & Data Management Daiichi Sankyo Co., Ltd.

Former leader of the CDISC Japan User Group (CJUG) ADaM team

Standards Updates

Membership Update

CDISC Around the Globe

Education and Training

Upcoming Events

Register now for our Interchanges in Asia.

In the News

CDISC Tools