Second Quarter 2020

CDISC Leadership

I hope that you and your loved ones are all safe and healthy.

With all the uncertainty over the last few months, I have found myself repeating a phrase my mentor, Dr. Jennie Hunter-Cevera, would say when things don’t go precisely as planned: “Onwards and upwards!” She meant and I mean, of course, that setbacks are temporary. And circumstances are only circumstances: we continue to move forward, continue to make progress, even during the unexpected.

Featured Articles

In late March, CDISC launched a task force with several member organizations and partners to rapidly develop an Interim User Guide for COVID-19 Leveraging existing work from virology and infectious disease Therapeutic Area User Guides, CDISC expedited its standards development process to deliver the User Guide in three and a half weeks.

CDISC is pleased to announce the release of our 2019 Annual Report. Review details on the past year’s successful performance, featured technologies and program expansion.

CDISC offers a number of online resources to help users make the most of CDISC Library (e.g., Release Notes , video overview of the data standards browser , API Documentation , FAQ.

The CDISC 360 team held a successful webinar “CDISC 360: The Journey So Far and the Road Ahead” on 28 April. It was very exciting to see the interest our industry and community has in the future of CDISC standards. Of the 1161 registrations, 807 attended! Equally exciting was that more than a quarter of the attendees submitted surveys, the majority with additional questions pertaining to the presentations. Following the webinar, the project team reviewed each comment and question, providing a response for every inquiry. The answers are posted, along with the presentations and the recording, on the Project Progress tab of the CDISC 360 page.

The CDISC website underwent a significant transformation, behind the scenes, migrating to a new platform to support our over 60,000 account holders who have access to over 4,000 webpages.

Chair, China CDISC Coordinating Committee(C3C)

EVP, Beijing Data Science Express Consulting Co., Ltd

How long have you been involved with CDISC?

In May 2008, a new colleague introduced CDISC to the company. It was my third year working in the clinical trial area, and I had summarized several key points on how to design a good CRF, and posted it on the web. After reading CDASH, I was surprised that CDISC standards were so professional, the best practice recommendation in CDASH was much better than what I summarized. Since then, I've been a CDISC fan.

Standards Update

CDISC is pleased to announce the release of version 1.1 of the Conformance Rules for SDTMIG v3.2 and v3.3. CDISC Conformance Rules allow users to evaluate conformance of the data structure to the standard.

The following Questionnaire, Ratings, and Scales (QRS) supplements to the Study Data Tabulation Model Implementation Guide (SDTMIG) have been published.

We posted more articles to our Knowledge Base, which features in-depth articles written by CDISC staff about implementing CDISC standards.

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 published two off-cycle releases for Glossary and Controlled Terminology in response to the COVID-19 pandemic. There are approximately 37 new QRS terms and 65 new terms across SDTM, SEND, CDASH, and CDISC Glossary.

CDISC released SDTMIG v3.3 in PDF on 16 June for those in our community who prefer to work with this format. Originally published (and still available) in HTML format, which expedites delivery of the standard, SDTMIG v3.3 is the most recent version of the Study Data Tabulation Model Implementation Guide for Human Clinical Trials.

Membership Update

CDISC is delighted to welcome new Platinum and Gold members to our community of over 460 global organizations as well as recognize our Star Members. We invite employees of members organizations to take advantage of the many benefits CDISC offers including our New Blending Learning and the Online Training Credit.

CDISC Around the Globe

Due to the COVID outbreak, in less than four weeks, the CDISC European Interchange, which was supposed to take place at the Titanic Chaussee Hotel in Berlin, was converted into a virtual conference, which took place 1 and 2 April.

Here comes big news! China released the Guideline on the Submission of Clinical Trial Data (draft for public review) on 6 May. It is a major milestone in the history of clinical trial data submission in China and a significant milestone for CDISC in China. Several C3C members devoted a lot of effort to the technical details in the Guideline.

The CDISC French-speaking User Network organized a webinar on  26 May where we discussed the following topics:

In light of the global COVID-19 outbreak, the CDISC UK Network produced a short video to introduce researchers to the resources available for COVID-19 and affected trials

We are planning a webinar in August with task force participants to look deeper into the details of the CDISC Interim User Guide for COVID-19 . Keep an eye on our wiki page for further details.

CDISC transitioned our annual conference in Japan to a virtual event (in response to the global pandemic), which took place 21 and 22 May. The J3C, speakers, sponsors, exhibitors and CDISC staff came together to pull off a successful event, which allowed attendees to listen to presenters in Japanese or English.

CDISC Education

In light of the global pandemic, CDISC has pivoted our public training to a new offering - Blending Learning - allowing our global community to take advantage of our in-demand courses virtually.

CDISC offers a variety of training resources online that allow you to take the training you need from the comfort and convenience of your home or office. Visit our online learning system to learn more and get started.

Webinars address industry hot topics, best practices and challenges around implementing the standards, allowing attendees to learn from the CDISC community of experts

Upcoming Events

The 2020 China Virtual Interchange is now accessible to all of Asia and the rest of the world via your internet connected computer or mobile device! This CDISC-hosted event will occur in three half-day segments, 5-7 August. Registration is now open. Don’t miss this opportunity to participate in a full CDISC Interchange from the comfort of your home or office.

Given the uncertainty of COVID-19 and many corporate travel restrictions, the 2020 US Interchange, originally scheduled to take place in Washington, DC, is going virtual. Dates remain the same: 7 - 8 October

In the News

Austin, TX – 15 June 2020 – CDISC has entered into a partnership with the Japan Agency for Medical Research and Development (AMED) to train leading academic researchers in Japan on standardizing data using CDISC standards.

Austin, TX – 05 May 2020 – CDISC has launched a project that will facilitate the use of electronic health record (EHR) data in clinical research to achieve efficiencies that expedite global regulatory reviews, contribute to the evaluation of new treatments for patients and drive next generation discovery.

Austin, TX – 22 April 2020 - CDISC has released an Interim User Guide, freely available on the CDISC website, which the research community can utilize to represent data in studies pertaining to COVID-19. The Interim User Guide provides examples and guidance on implementing CDISC standards for COVID-19 so that researchers can collect, structure and analyze data more effectively.

Austin, TX – 27 MARCH 2020 - CDISC has launched a task force to rapidly develop guidance on standardizing COVID-19 research data with the participation of several member companies. This guidance will be released in the form of an Interim User Guide and will be made freely available on the CDISC website. Researchers around the world can leverage the User Guide to represent data in studies pertaining to COVID-19 to expedite the regulatory review process, reduce time to market, and drive operational efficiencies within their organizations. US FDA is aware of and observing the work of the task force.