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Third Quarter 2017

CDISC Leadership

My mentor used to say “Show me your friends, and I will see you.” Our peers reflect who we are.

These past few months I have been on the road, three continents and nine countries, meeting the individuals and organizations that form CDISC’s global community of friends, partners, volunteers, members, and government regulators. I think if anyone judges us by our friends, CDISC will be proud of the reflection.

Featured Articles

CDISC is pleased to announce the release of CDASH v2.0. CDASH v2.0 comprises the CDASHIG v2.0, the CDASH Model v1.0, and CDASHIG metadata tables to define basic standards for the collection of clinical trial data and how to implement the standard for specific case report forms. This major release represents hundreds of volunteer hours - meeting, planning, discussing, reviewing, updating and QC-ing – and the combined experience and dedication of dozens of experts. We are profoundly grateful to our volunteers and staff for their hard work accomplishing this significant achievement. 

In an August Members-Only webinar, we discussed the CDISC evolution in an effort to deliver more transparency, accountability, and predictability with new and updated procedures and processes including:

  • New Annual Release Schedule
  • Updated Standards Development Procedure
  • New Volunteer Engagement Procedure

CDISC hosted our Summer Working Groups in Silver Spring, MD 25 - 27 July. CDISC Working Groups are an opportunity for those involved in our standards development teams to meet face-to-face to work collaboratively across teams to further standards development efforts, share knowledge and experience. We also spent some time honoring our dedicated volunteers with Team Awards, including handmade crowns by our own Darcy Wold.

 

The CDISC China Interchange returned to Beijing  21 - 22 Sept 2017 after a six-year hiatus. CDISC Representatives in attendance included Dr. David Hardison, Board Chair; David R. Bobbitt, President and CEO; Rhonda Facile, VP, Standards Development; Dr. Lauren Becnel, VP Strategy and Innovation; Sheila Leaman, VP Membership and Events, and Kit Howard, Director, Education.

CDISC is working with the global sponsors on the Clinical Trial Registry (CTR2) Project, which will  extend and enrich CTR-XML by including summary results, extending Protocol elements, and harmonising the CDISC Foundational Standards with the ISO IDMP Standards. In concert with the CDISC SHARE metadata repository, this project will utilize and extend CDISC Foundational Standards to create richer and reinforced beginning-to-end data sets that meet many complex competitive and regulatory demands.

The CDISC Education team has worked diligently to align our methodologies, processes and procedures to a recognized industry standard published by the International Association for Continuing Education and Training (IACET).  We are pleased to announce we successfully completed an intensive audit process and received accreditation from IACET. CDISC Education is now the only IACET-accredited training organization in the world authorized to teach CDISC standards.

LOINC is coming! The U.S. Food and Drug Administration will require LOINC codes to be utilized in clinical research submissions of human lab data. The FDA has held a series of meetings with representatives from CDISC, National Cancer Institute’s Enterprise Vocabulary Services, the NIH National Library of Medicine and Regenstrief Institute to provide input into the development of information for stakeholders for the implementation of LOINC in clinical research.

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.

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.

SHARE API 2.0 Public Input

CDISC SHARE is a curated resource that makes it easier to implement CDISC standards in electronic systems such as clinical data management systems, mobile apps, and learning health systems. It also increases accessibility of these standards to programmers, data managers and biostatisticians. Implementing CDISC SHARE’s standards can facilitate collecting, aggregating and analyzing standardized data from early design to end analysis. 

Since Study Data Tabulation Model Implementation Guide for Pharmacogenomics and Pharmacogenetics (SDTMIG-PGx) was published, genetic analysis of clinical or non-clinical samples has continued to become a standard practice and the methodology for generating these data has continued to evolve.

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

Membership Update

The CDISC 2017 International Interchange is a five-day event held 13 - 17 November at the Hyatt Regency Austin in Texas. The program includes CDISC training courses Monday, Tuesday and Friday; the main conference takes place Wednesday and Thursday. Clinical Research Professionals from around the world gather to share progress, use cases, and strategic ideas on implementing CDISC standards to foster smarter research. Register now as space is limited! 

CDISC Alliances

The UK medical research sector is not alone in its search for ways to streamline clinical research and enable connections, this is a challenge faced by research communities across the US and the globe. CDISC is on a mission to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.

Thank you to everyone that participated in the CDISC-PhUSE QRS Roundtables this past month. The Roundtables were attended by the FDA, CDISC, and PhUSE members.

CDISC Around the Globe

The European Coordinating Committee (E3C) has a longstanding tradition of being the key CDISC representatives in Europe. This is a group of experienced, industry thought leaders that serve for a period of three years as volunteers, supporting CDISC initiatives in Europe to support the global adoption of standards

The European Coordinating Committee is excited to welcome six new members to our 2018 Committee

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CDISC User Networks share CDISC implementation experiences periodically in a given region or language, discuss draft and mature standards and participate in public review, offer comments, as well as circulate feedback and new ideas to CDISC, network among colleagues, and share recent conference participation and learning experiences.

PharmaSUG China Annual Meeting was held in Shanghai in July 7-8, 2017.  Seven out of 18 C3C members attended the meeting as speakers, session chairs and discussion panelists.  The CDISC China booth became the center point for our members to gather and take pictures.  

Call for Nominations for the 2017-2020 Japan CDISC Coordinating Committee (J3C) Chair

As an interested party of CDISC, you have the opportunity to participate in the process of nominating a Chair for the CDISC Japan Coordinating Committee. Nominees must be from a CDISC member organization. The Chair will serve a three-year term from 2017-2020. 

CDISC Education

CDISC offers public, members-only, and technology webinars and mini-training sessions throughout the year to help stakeholders make the most of the standards.

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

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

Learn CDISC from CDISC!

NORTH AMERICA

Public Courses in Austin, TX
13 - 17 Nov 2017

Upcoming Events

In the News

Keep up to date with the latest developments at CDISC.