Frank Newby, CDISC Chief Operating Officer, provided an update this year, rather than having each team leader provide a separate presentation for their team’s update. The rationale goes like this…..
CDISC now has a full set of production standards to support the research process from Protocol through Analysis and Reporting; hence, CDISC teams leaders (Technical Leadership Committee – TLC) and Operations Technical Staff (under the leadership of Frank Newby) are reviewing the way that CDISC standards could and should be developed in the future. The CDISC SHARE stakeholder analysis and feedback from FDA have made it clear that there is a desire on the part of CDISC users to augment the CDISC Safety Data domains with those that will support Efficacy data. These important data should not be buried in a SUPPQUAL domain or some other place that may make it difficult to find. And, there is no reason to augment the Terminology, CDASH and SDTM separately; hence, the process for developing efficacy standards related to specific disease/therapeutic areas should be cohesive and concurrent and the CDISC teams should be working on cross-team projects going forward while the existing standards are refined and maintained. The CDISC Operating Procedure for Standards Development is being discussed and will be updated to include more information on the augmentation of CDISC standards across teams. More information on healthcare developments will be in a later Blog (so keep checking here!).
Cross-team efforts being the theme this year, each team developed a poster and these were placed around the Exhibit area as well as a special link to them on our website for attendees. Frank Newby also gave a brief Technical Overview of highlights from each team and indicated the following themes going forward:
- More emphasis on cross functional projects
- Curation team for current standards
- Maintenance
- New development
- Enhanced Project Management
- Updated COP-001
- Updated Roadmap
Frank also gave updates on CDISC Events/Interchanges and the Finances, stating that CDISC has remained net positive over the first three quarters 2010, reducing some of the deficits from the last two years. He closed by showing the website where everyone can freely and openly access the Standards and Innovations from CDISC and how to Contact CDISC Operations staff.
Shannon Labout, CDISC Director of Education showed the audience the new CDISC Education Logo, which indicates that the CDISC education you are receiving is CDISC-authorized! She proceeded to explain what the new CDISC Logo really means to anyone taking CDISC educational courses.
The CDISC Operating Procedure for Education (COP-005) controls:
- How training materials are developed
- How trainers are qualified and selected
- Training materials
- Developed under the authority of CDISC TLC
- Developed by a multi-organizational team
- Reviewed by the technical team
- Trainers/Instructors
- Assurance of minimum qualifications
- In many cases the same trainers who train the FDA (SDTM/ADaM)
Shannon also gave updates on the current courses, new courses and coming courses. There is information on all of these on the CDISC website under Education and Events.
The session closed with updates from each of the leaders of the CDISC Coordinating Committees. In the photo below, from left to right are the leaders from the newest to the most established of the “3Cs”: Dr. Sukil Kim, leader of the Korea CDISC Coordinating Committee (K3C), established in July of 2010; Simon Wang, leader of the China CDISC Coordinating Committee (C3C), established in 2008; Dr. Yoshio Tsukada, leader of the Japan CDISC Coordinating Committee (J3C), established in 2002; and Dr. Pierre-Yves Lastic, leader of the Europe CDISC Coordinating Committee (E3C), established in 2001.
Bron Kisler (furthest to the right in the photo) chaired this session. As he stated, it was a pleasure and a privilege that these leaders were all present at the Interchange in Baltimore to personally give their presentations on progress around CDISC in their regions of the world. There were also several mentions of a potential ‘Asia 3 C’ in the future. We will all have to stay in touch to see what that may bring.
The afternoon of the first day of the Interchange (3 November 2010) was split into two tracks to accommodate more of the abstracts that were received. These sessions focused on ODM Implementation; Standards from the Start: CDASH and Protocol; Submission Standards: SDTM and ADaM; and CDISC SHARE and Metadata Repositories.
Abstracts were selected by the Programme Committee, which was comprised of volunteer representatives from the CDISC Advisory Board (CAB) and leaders of User Networks in North America. (Jonathan Andrus, Chris Decker, Dave Evans, Dave Gemzik, Dan Godoy, Kalyan Gopalakrishnan, David Handelsman, Brooke Hinkson Marcelina Hungria, Tammy Jackson, Gary Walker, Peter Schaefer, Trisha Simpson, Peter Van Ruesel , Robert Van Manen, Julia Zhang. This was a critical group rating criteria were broad, including the following (along with comments):
- Overall Quality
- Key CDISC Messages
- Freshness vs. Old News/Topic
- Forward-Thinking
- NOT Overlapping CDISC Educational Courses
- Attractive to new audiences
- Neutrality (NOT a vendor ad)
We would love to hear your feedback on our updates and what you would like to hear about in the future. Please feel free to comment below.
Dr. Rebecca Kush
CDISC President and CEO
swim caps