First Quarter 2020

CDISC Leadership

It is cherry blossom season here in the Washington, DC, area where I live. The trees quietly slumber all winter and then in unison, different varietals flower at just about the same time. It is beautiful to behold! No one knows exactly when peak bloom will occur. Like the cherry trees, we must be ready to bloom.

Featured Articles

CDISC derives our strength from the individual perspectives and collective power of our community of volunteers. Whether coming from a pharmaceutical organization, academic institution, regulatory agency, non-profit, or beyond, our volunteers bring a range of experiences and backgrounds to facilitate the development of standards that are open and available to all to drive more meaningful clinical research.

Focus on the CDISC 360 project among the CDISC community has increased steadily since the project’s launch. The project's ambitious goal to innovate clinical data standards as concept-based standards and store them in the CDISC Library as linked metadata has gained increasing interest from CDISC Member organizations and beyond, including Pharma and Biotech sponsor organizations, service organizations, and technology vendors.

Our members continue to leverage CDISC Library, the single, trusted, authoritative source of CDISC standards metadata and a new way of creating, maintaining, and publishing this metadata. To date, over 150 member organizations have created accounts on CDISC Library to support greater efficiency throughout the clinical research lifecycle.

If your organization has not taken advantage of CDISC Library, create an account today and get started.

CDISC has been involved, for well over a decade, in initiatives that support and develop ways to manage clinical research and healthcare integrations in the context of electronic source data (eSource). Our initial work commenced when CDISC began in 1997 with the Healthcare Link Initiative, which officially launched in 2004.  Since then, CDISC has participated in HL7’s Connectathons, eSource Thought Leaders Forums, and the TransCelerate eSource Roundtable. We have also collaborated with regulatory authorities, partners and fellow standards development organizations on a number of eSource projects.  Most recently CDISC has begun exploring the use of CDISC standards outside regulated clinical trials, specifically academic research with the launch of “CDISC RWD Connect”. 

TechniCon, which took place in January, was CDISC’s first virtual conference, and showcased technology solutions from CDISC member organizations as well as open source developers. CDISC also took the opportunity to showcase CDISC Library and CDISC 360. We wanted to host such an event to allow attendees to see demonstrations of these solutions and hear directly from developers from the convenience of their homes or offices.

How long have you been volunteering at CDISC?

I started in Jan 2008

What encouraged you to volunteer your time and expertise with CDISC?

Federal Register /Vol. 72, No. 191 /Wednesday, October 3, 2007 announced that the FDA was looking for 5 to 8 organizations to participate in a three-year pilot of SEND.  The head of Toxicology at BMS at the time wanted BMS to participate and asked me to join the SEND team.

Standards Update

It was with great pleasure that we released the first set of Conformance Rules for SENDIG. SEND is an implementation of the SDTM standard for nonclinical studies and is one of the required standards for data submission to US FDA.  Using SEND allows nonclinical data to be structured effectively and easily analyzed, leaving more time for researchers to focus on discoveries that will have invaluable impact on global health.

CDISC, with support from our partner TransCelerate Biopharma, is developing version 2.0 of the CDASH SAE Supplement, an update to CDASH SAE Supplement v1.0, released in 2013. CDASH SAE Supplement v2.0 will capture how to structure serious adverse events (SAE) concepts for regulated clinical trials. It will also align with E2B (R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide – Data Elements and Message Specification and bring the standard up to date with current 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.

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

Membership Update

A new year means a new certificate for your organization. Starting January 2020, all renewing members will receive a digital copy of the certificate instead of a hard copy. Members can print the digital copy and replace it with the 2019-2020 member certificate pictured above. New members will receive a CDISC hard-copy certificate with display frame. We encourage you to display this certificate in your offices as well as at conferences.

CDISC Around the Globe

The CDISC French User Group is pleased to have on-boarded six newcomers in 2020:

CDISC President and CEO David R. Bobbitt traveled to Japan in January to encourage more adoption of CDISC standards and foster a deeper knowledge of their use among Japanese stakeholders. David, along with members of the J3C and CDISC Board Members, Hiroshi Masumoto and Mihoko Okada, met with various organizations to discuss how CDISC standards drive operational efficiencies within the organizations that use them, expedite the regulatory review process and reduce time to market.

March has been a busy season in Japan with the end of the transition period approaching on 31 March for the PMDA’s e-submission requirements. March is also the end of many Japanese companies’ financial periods. CJUG members have been hard at work making final preparations for the PMDA mandate.

With the recent successful series of CDISC Technicons, the UK User Network did not hold a webinar in Q1. We will look to host our next event on 5 June. Visit our Wiki page for information and to listen to our last webinar.

In February, Oxford University’s Infectious Disease Data Observatory (IDDO) invited me to attend a workshop in New Delhi, India to support an effort to standardize data for visceral leishmaniasis (VL), a potentially fatal parasitic disease transmitted by sandflies. The two-day workshop was hosted at the offices of Drugs for Neglected Disease Initiative (DNDi), a non-profit drug research and development organization that is developing new treatments for neglected diseases. Moderated by team members from IDDO, the workshop convened subject matter experts from around the world with the goal of reaching consensus on what data should be collected to support VL treatment and prevention.

The San Diego CDISC Users Network (SDCUN) held a meeting at the Pfizer campus in La Jolla, CA on 20 February. The Network seeks to facilitate the San Diego stakeholders’ learning, sharing, and contributing in CDISC and industry topics. Sponsored and organized by PharmaStat LLC, along with industry leaders Dave D’Attilio (TalentMine), Ren-Yu Tzeng (Pfizer), Sandra Minjoe (PRA Health Sciences), and Sheila Leaman (CDISC), the meeting boasted a robust agenda covering a wide range of industry topics.

CDISC Education

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.

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

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.

Join us for one (or more!) of these upcoming webinars.

Upcoming Events

Get the full experience of a CDISC Interchange from the comfort of your home or office for only $185 USD

In the News

CDISC Adds Four New Members and Re-appoints Two to 2020 Board of Directors

AUSTIN, TX – 15 January 2020 – CDISC today announced four new members have joined its Board of Directors: Dr. Wenjun Bao, Dr. Mihoko Okada, Dr. Erik Pulkstenis, and Dr. Christina Reith. Each began serving a three-year term at the beginning of the year. These members join current, sitting members, including David Evans and Steve Rosenberg, who will each be serving a second three-year term.

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.

Attention all clinical data managers: The US Department of Labor is interested in learning more about your role to help ensure tthe complexities of your profession are described accurately in the Occupational Information Network (O*NET) database for the American public. O*NET is a free resource for millions of job seekers, employers, veterans, educators, and students. Visit this link and share your input today!