Almost fresh faces for me. It’s nice to meet Jack Shostak of Duke Clinical Research Institute again. I visited him in Duke last year after SAS Global Forum in Las Vegas. Jack has a forthcoming book on SAS and CDISC, Implementing CDISC Using SAS: An End-to-End Guide. It’s the first book on this topic and worth waiting!
I also met (unexpectedly and exciting) a Chinese friend Chunmao in the meeting. Very interesting: after introduction, then we got that we emailed on CDISC mapping before! Chunmao just moved from DC to Triangle as SAS programmer weeks before(a side message: Triangle is hiring!). Big bonus to attend this meeting.
My colleague Chris Decker of d-Wise Technologies also showed up in this meeting. Actually he and Jack both serve as committee members in RTP CDISC User’s Group (they are also core members in CDISC community worldwide).
Tom Soeder of Cato (venue supplier for this meeting) kindly served as host while Jeff Abolafia of Rho the moderator.
Jeff and another key member of this group introduced some important updates from CDISC. One of the most interesting messages for me is the regular release cycle of SDTM Model and Implementation Guide. SDTM will be released semiannually, so we will get SDTMIG 3.1.3 in this summer, 3.1.4 at the end of year which will mainly hold the recently updates of Trial Summary, an amendment, and CDISC Devise domains respectively.
SDTM is the flagship model of CDISC. SDTMIG 3.1.1 published in 2005 while 3.1.2 in 2008. It’s nice to see from the new more frequent release schedule that the CDISC community is expanding (and more organized and expected).
Recently SDTM does have lots of updates, including a copy of the Metadata Submission Guideline (MSG). CDISC organization will also offer periodic webinars on updates.
Chris then gave a summary on latest FDA/PhUSE Computational Science Symposium (CSS while Chris organized it). You may get more information on Chris’s blog, and CDISC blog. It’s better to keep CSS in watch list.
Jack and Jeff had comments on working the FDA/PhUSE working groups.
Peter Schaefer of Certara released the outputs of latest CDISC user network servey where SDTM and ADaM are still on the top of user’s list.
Final part (most practical), group exercises! Three groups were assigned to map some challenging CRF pages to SDTM. Some users also took some CRF pages from their own companies for public discussion (nice to have some flavors!).
RTP CDISC User’s Group on Yahoo Group (the traffic is low but still informative):
CDISC official site:
Now we have more reasons to visit CDISC website frequently for new updates models (e.g., Control Terminology also released semiannually) and webinar postings.
FDA/PhUSE working groups Wiki:
Lots of action followed by the six working groups.
Chris is one of the core members to promote CDISC among industry and regulator and he is also the most active blog writer on d-Wise blog and you can get informed: