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Second Quarter 2017

CDISC Leadership

Hello! It is a privilege to serve as the new CEO at CDISC.  I’m David Bobbitt, and I look forward to working with you to build an even stronger organization, supporting our stakeholders and members. Over the last two months, I’ve traveled to three continents to meet with CDISC stakeholders from industry, academia, and government agencies. I was privileged to attend the Europe Interchange and the Japan Interchange, and I must say a huge thank you to the E3C and J3C volunteers who made each conference a success in terms of content, attendance, and spirit.

Featured Articles

CDISC collaborates with the Critical Path Institute (C-Path) to develop Therapeutic Area Data Standards for multiple disease areas through the CFAST initiative.

The article, Accelerating drug development for Alzheimer's disease through the use of data standards in the Alzheimer's & Dementia: Translational Research & Clinical Interventions, a Journal of the Alzheimer’s Association highlights the development and impact of our Therapeutic Area Data Standard for Alzheimer’s disease. 

 

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.

In this edition of our Volunteer Spotlight, we’d like to highlight the hard work and dedication of Kamiar “Mike” Hamidi, Associate Director, Global Clinical Data Standards at Merck & Co.

BRIDG (ISO:14199) is an international standard biomedical research domain information model developed by stakeholders including CDISC, the National Cancer Institute, the Food and Drug Administration, Health Level 7 (HL7), and International Standards Organization (ISO).

Accelerate to Innovate, newsletter from our partner, Transcelerate Biopharma Inc., features a Spotlight on Clinical Data Standards Brooke Hinkson, Head of Clinical Data Standards at Merck, who explains how TransCelerate’s Clinical Data Standards Initiative is foundational to clinical trial process efficiencies.

Shared Health and Research Electronic library (SHARE) is our metadata repository that provides computer-readable versions of CDISC standards to improve collecting, aggregating and analyzing standardized data from early design to end analysis. CDISC is the only Standards Development Organization to free standards from PDF and deliver them electronically.

In the 04 June 2017 of Applied Clinical Trials, CDISC's VP of Strategy and Innovation, Dr. Lauren Becnel...

Standard Updates

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.

CDISC Transport Standards enable the exchange of data conformant with CDISC Foundational Standards and their Therapeutic Area extensions.

CDISC, in collaboration with a variety of stakeholders, is developing Therapeutic Area (TA) standards through the Coalition for Accelerating Standards and Therapies (CFAST) initiative. 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.

SHARE 2.0 Public Input

CDISC invited the community to provide Public Input for SHARE 2.0, a major upgrade of the current SHARE model. SHARE 2.0 includes significant improvements, such as better separation of SENDSDTM, and ADaM from their implementation guides, the ability to map Therapeutic Area (TA) Standards to the Foundational Standards, and a link from Controlled Terminology to their appropriate standards.

We load the CDISC Controlled Terminology (CT) published by the NCI Enterprise Vocabulary Services (EVS) into the SHARE metadata repository (MDR). When we're through catching up with our backlog we'll have more CT in SHARE than any other type of metadata, and we'll publish the quarterly CT content to the SHARE Exports page on the CDISC web site. One of the main differences in how we load the CT is that we load only the incremental changes.

CDISC Semantics provide context, content, and meaning to clinical research study data, and improve access and use of CDISC standards in practice.

 

Membership Update

We want to remind you that CDISC Membership not only allows the standards to remain open and freely available, but also provides many benefits to ALL employees of CDISC Member organizations.  

A warm welcome to our new members in the 2nd Quarter 2017

Platinum Members

Altria – United States

Centers for Disease Control / National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention – United States

Nurocor – United States

University of Oxford – United Kingdom

In the News

CDISC Alliances

A CORBEL taskforce has finalized a consensus document which provides principles and practical recommendations on how to share individual participant data from clinical trials, with a focus on non-commercial trials.

CDISC is proud to have been featured as a partner with the FDA in their 2015-2016 Regulatory Science Progress Report highlighting their efforts to collaborate with Scientific Consortia to ensure the safety quality and efficacy of medical products.

CDISC Around the Globe

Nearly 300 attendees came together from 25 countries on four continents in London from 24 – 28 April to network, learn best practices and discuss current state and future vision for CDISC Standards development and implementation in clinical research and healthcare.

Laura Merson delivered the opening keynote on her efforts to “Leverage global expertise to address the barriers to research in Epidemics” and the important role data standardization can play in proactively responding to infectious disease outbreaks. Her efforts to improve public health, over the past 15 years, have contributed to developing standardized, open-access research protocols designed for outbreak response.

2017 CDISC Europe Interchange

I invite you to read my blog post, Reflections on Dr. Hans-Georg Eichler's Closing Keynote at the CDISC 2017 Europe Interchange

Nominations to the CDISC European Coordinating Committee

We are recruiting volunteers for 2017-2018 E3C. Send your CV to communications@cdisc.org to help guide CDISC activities in Europe. Nominations close 15 July.

 

The rainy season and hydrangeas…what a lovely time to be in Tokyo for the CDISC Japan Interchange.

The Japan CDISC Coordinating Committee (J3C) held another successful Interchange this June, attended by over 250 people, making it one of the largest Japan Interchanges in CDISC history. CDISC would like to thank the J3C for their incredible support of the Japan Interchange every year, assisting on the Program Committee, working on the site logistics, serving as session chairs, planning meetings, and much, much more. Additionally, we would like to thank the CDISC Japan User Group (CJUG), Pharmaceutical and Medical Devices Agency (PMDA) and Japan Agency for Medical Research and Development (AMED) for meeting with us the week of the Japan Interchange, and for their support of CDISC in Japan throughout the year.

DIA China 9th Annual Meeting was held in Shanghai in May 21-24, 2017. Yazhong Deng of TrustCRO magically got a complimentary booth for China CDISC Coordinating Committee (C3C) two days before the meeting.

CDISC Education Opportunities

Join us at an Upcoming Webinar

18 JUL 2017 10:00 AM CDT - Controlled Terminology Quarterly Updates​

This webinar will highlight changes to Package 30 CT, which will be published 30 JUN 2017 and will discuss the public review period for Package 31, which runs from 23 JUN 2017 to 21 JUL 2017. 

Learn CDISC from CDISC!

CDISC authorized education courses actively engage learners to improve the quality, efficiency and cost effectiveness of clinical research processes from protocol through analysis and reporti

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

The CDISC Education Team developed an informative poster that explores the differences between CDASH and SDTM and explains why both standards are critical. The team has presented  this poster at the CDISC Europe and Japan Interchanges as well as PhUSE events.

Upcoming Events

The CDISC Executive Team invites you to attend the 2017 CDISC Summer IntraChange, 25-27 July at the Silver Spring Civic Building. 

This meeting is a working group meeting for all CDISC Volunteer Teams - Foundational Standards, Transport Standards and Therapeutic Area Standards - to work together face to face to accomplish the 2017 Team Goals.

Agenda2017 Summer IntraChange Agenda (subject to change)

Registrationhttp://www.cvent.com/d/k5q331/4W

Nearby HotelsCourtyard MarriottDoubletree by HiltonSheraton HotelHampton Inn by Hilton

You can read about the 2017 CDISC Winter IntraChange here.

Join CDISC in Beijing!

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The China CDISC Coordinating Committee (C3C) is now accepting abstracts. Our goal is to provide attendees with informative and resourceful content to foster the global adoption of standards. Please send your submissions to the CDISC Events Team at events@cdisc.org. This is your opportunity to help shape the conference program and share your expertise. Submission deadline is 21 July 2017.

Join CDISC from our headquarters in Austin, Texas 13 - 17 NOV 2017

2017 CDISC International Interchange

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Join CDISC partners at conferences around the world.

SCDM 2017 Annual Conference

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PhUSE Annual Conference 2017

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