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CDISC Leadership

“Great things in business are never done by one person; they're done by a team of people."  – Steve Jobs

As 2017 comes to a close, I’d like to acknowledge CDISC’s two greatest assets….our staff and the global CDISC community. Together, these teams have indeed done, and will continue to do, great things. 

Featured Articles

As we travel around the globe, meeting and interacting with our stakeholders, CDISC is listening. We hear you and are committed to doing everything we can to support our community and to make the standards better.

At our International Interchange last month, I presented during our Opening Plenary session on What’s New and What’s Next at CDISC, and want to share some of that information with the CDISC community in this newsletter article.

The 2017 International Interchange, held in Austin, Texas, was an incredible success. With 525 attendees from 183 organizations, from 16 different countries, the conference week was an informative and bustling event. Attendees had the opportunity to attend 11 different CDISC Education courses, listen to and liaise with over 80 speakers and panelists presenting on 20 hot topics, and network with industry peers.

During the September 2017 PhUSE webinar, CDISC CEO David Bobbitt spoke to a "new day at CDISC". We, at PhUSE, believe the 2017 CDISC International Interchange exemplified this mantra. Shannon Labout, CDISC Interim Chief Standards Officer, delivered a thoughtful, well- received presentation during the plenary session about the ongoing evolution of CDISC.  Ms. Labout described the framework for a "new day" that PhUSE believes will be welcomed by standards developers and implementers alike.

Looking forward to the day when all infectious disease data is collected and stored in a common format, data managers from the Infectious Diseases Data Observatory (IDDO) said their recent CDISC training has encouraged them to move ahead with plans for a more integrated approach.

In 2017 the United States Food and Drug Administration (FDA) convened a Logical Observation Identifiers Names and Codes (LOINC®) Working Group to make recommendations to the Agency regarding the forthcoming mandate to submit LOINC codes to regulators. This Working Group was a collaborative effort among the FDA, National Cancer Institute, National Library of Medicine, Regenstrief Institute and CDISC.

CDISC relies on the subject matter expertise of thousands of volunteers to create vendor-neutral, platform-independent data standards that enable information system interoperability to improve clinical research.

This quarter's Volunteer Spotlight features the new chair of CDISC European Coordinating Committee (E3C), Joerg Dillert.

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.

The CDISC Foundational Standards are the basis of the complete suite of harmonized CDISC standards, designed to enhance the quality, efficiency and cost effectiveness of clinical research processes from beginning to end.

Study Data Tabulation Model (SDTM) v1.6 and Standard for Exchange of Nonclinical Data Implementation Guide: Developmental and Reproductive Toxicology (SENDIG-DART) v1.1 Release

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.

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.

Since starting work on ODMv2 earlier this year the CDISC XML Technologies Team has made quite a bit of progress detailing proposed changes and new features. Much of this work is progressing concurrently, creating a broad set of ongoing discussions. To follow the ODMv2 development work the best place to begin is the ODM-XML page in the XML Tech space on the CDISC Wiki. Here you can find a list of the most recently updated pages, a list of JIRA tasks, a link to the decision log, and links to most other relevant aspects of the project

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

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CDISC Around the Globe

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AP3C Looking for More Members

Three C3C members, Dr. Zibao Zhang, Executive Director and John Wang, Associate Director from dMed Biopharmaceutical Co. Ltd. and I attended the CDISC Interchange in the US for the first time.

On October 12th, The University of Tokyo Faculty of Medicine (UMIN) hosted an open CDISC symposium with co-sponsor, AMED. The Symposium "Improving Efficiency of Clinical Trial Data Management using CDISC Standards" welcomed 95 participants from national research centers, medical institutions, academia, university officials, pharmaceutical companies, CROs and vendors.

The CDISC French-Speaking User Group (GUF) held our second event of the year in Brussels, on 27th September 2017, hosted and sponsored by SGS Life Sciences at the great Brussels Pullman Hotel. There were around 70 registrations and the room was almost full.

The conference was introduced by Xavier Gobert (MyData-TRUST), who leads the French committee and is part of the E3C committee.

“Esempi pratici di Implementazione dello standard CDISC-ADaM” (Practical Examples of CDISC ADaM Implementation)

About 45 professionals from various Italian pharmaceutical companies and CROs attended the 5th Italian CDISC User Group 27 October 2017 at the University of Milano-Bicocca in collaboration with BIAS (Biometrics Italian Association). Five students from the local statistical faculty also attended the event.

The CDISC UK Group held a teleconference in October to discuss CDISC Harmonisation. The following is a synopsis of the call.

CDISC Education

In October, I traveled to Kampala, Uganda to conduct CDASH training for the US NIH’s National Institute of Allergy and Infectious Diseases (NIAID) at the Infectious Disease Institute (IDI).

CDISC Education is pleased to announce the first authorized Japanese translation of the Controlled Terminology Online Training--Overview of Terminology.

This module covers:

CDISC Public Webinar Series - CDISC Newcomers Webinar

THU, 18 JAN 2018 10:30 AM - 11:30 AM CDT
REGISTER NOW

Description

CDISC Public Training courses provide expert-led training sessions 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 at one or more of the courses below to Learn CDISC from CDISC!

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

CDISC standards courses are available for in-house delivery by our authorized instructors anywhere in the world*.

CDISC in-house training:

1.     Utilizes authoritative training materials developed by the standards teams

2.     Is delivered by an instructor qualified by the standards team

3.     Provides your staff with authorized CDISC training certificates

4.     Ensures confidentiality, allowing your attendees to work on real issues during class

Upcoming Events

Mark Your Calendars for these 2018 CDISC Events!

 

CDISC Europe Interchange 23 – 27 April 2018 Berlin, Germany

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