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Enhancements to SDTMIG v3.2

SDTMIG v3.2 features many enhancements and improvements to make updating and maintaining future versions more efficient, as it continues to grow to support new Therapeutic Area data standards and respond to the expanding global community of implementers. These enhancements and improvements include:

Is Collaboration in Research a Pipe Dream?

Researchers have traditionally been rewarded for innovation and being the first to publish unique results.  Unfortunately, in a new era promoting collaboration, such a culture presents barriers to sharing information in a timely and useful manner and, in turn, to bringing therapies to patients sooner. Certain organizations such as One Mind are trying to change this culture.   


The theme of the 2015 One Mind Summit was “Open Science and Collaboration in Action.” Examples of One Mind collaborations were presented by key opinion leaders, while barriers to further collaboration were identified in a fluid exchange of great ideas mixed with cautious optimism about what changes can actually be achieved.


Impediments to successful collaboration in Traumatic Brain Injury (TBI) discovery in the U.S. were shown on a slide by one of the world’s leading experts in this field during the panel discussion “TBI: A Field Moving from Competition to Collaboration.” These impediments, which are not limited to TBI, include:

  •         A societal culture that values individual discovery;
  •         An NIH funding culture that favors individual research and discovery;
  •         An NIH funding culture that emphasizes innovation and impact, which are not necessarily major components of collaborative research.

Helping is my Focus

Today is the second day of the Interchange, and I've spent most of my time at registration. I'm not actually assigned to be there today, but I tend to gravitate towards registration at Interchanges, because it's one of the best places to be on hand to help. I'm CDISC staff: helping is my purpose here. 


It's no hardship. I enjoy hanging out with my fellow staff, and helping people is always satisfying. Even if I can't answer a question or solve a problem, I can at least hear it, and hopefully pass it on to someone who can. When I'm not needed, there's a table and I can doodle away to my heart's content. 


I was the time keeper for Session 5, which was tightly packed with a lot of speakers. I sat in the front row with a stop watch and a list of expected times for each presentation, and as time ticked by, I would change out signs to show how much time was left: "10 minutes" ... "5 minutes" ... "Time's up!" 


It can be hard to cut someone off, especially when they're in the middle of an engrossing thought, but it's not fair to the other speakers to let them

run over their allotted time, and it's not fair to the audience either.

Patients - The Main Focus of the International Interchange

The patient was the main character in the 2015 CDISC International Interchange.  Whether it is our friends, family, neighbors, or ourselves, we are all patients.This year’s Interchange focused on the patient and how quality data ensures that the patient is receiving the best possible care and treatment and how quality data can unlock cures.Patients and families now have access to much more information and truly do want to share their data to improve healthcare, but without standards, this data is often very difficult to share. 

SHARE Booth Experience at the International Interchange

“Is SHARE available now?”
“How do I access eSHARE?”
“What kind of metadata is available in SHARE now?”
“What can I do with SHARE metadata?”
“What is new in SHARE for 2016?”



This is a sample of frequently asked questions at the SHARE booth during the Interchange; the SHARE and eSource demonstration booths were conveniently situated outside the conference break room, where attendees enjoyed their meals and refreshments. With guaranteed foot traffic, the location maximized our opportunity to socialize SHARE’s values and benefits. We set up a TV monitor at the SHARE booth, looping a presentation slide deck that details what the team accomplished in 2015 and planned for 2016. To the right was the SHARE poster set on an easel. The CDISC model on the poster facilitated many conversations. It diagrams the lay of the land of all CDISC products in a simple way. It depicts product relationships and identifies SHARE deliverables in a single bird’s-eye view.

CFAST TA Session at the International Interchange

The well-attended CFAST Therapeutic Area session was filled with presentations from several different perspectives.   The goal for the session was to expose attendees to some of the projects and topics that TA teams are working on and provide as much information as possible about new approaches, tools and available standards.


The session began with Rhonda Facile, CDISC, describing the governance and current status of CFAST TA projects.  To date, the CFAST program has published 16 TA User Guides (TAUG) and there are 18 ongoing projects with 6 targeted for completion in 4Q15/1Q16.  7 more projects have been approved by the Steering Committee (TAPSC).  


Dr. Mayumi Shikano from the Pharmaceuticals and Medical Devices Agency informed attendees about the PMDA’s plan to create a J-CFAST organization to develop TA standards in Japan and provide input into published and emerging CFAST standards in the US and EU.  


Jerry Salyers from Accenture presented on “Data Standards, Considerations & Conventions within TA User Guides” in a style that was both informative and entertaining.   Jerry concluded by stating that CFAST has “accelerated standards development and this has resulted in a number of new SDTMIG domains, variables and modeling strategies.” He expected this to remain the trend.

Healthcare Link

Healthcare Link was well-represented at this year's CDISC International Interchange meeting in Chicago.  On Day One, the eSource Stakeholders Group Informational Meeting took place.  This was an open meeting to help get the word out about the recent FDA Federal Register Notice encouraging "Source Data Capture From Electronic Health Records: Using Standardized Clinical Research Data."[1] The meeting attendance reflected the wide mix of stakeholders involved in this effort, including biopharma, academic medical centers, EDC vendors, and CROs.  After introductions, Alana St. Clair of CDISC took the group through a general review of the FR Notice to ensure everyone started with the same understanding, then the group engaged in an open discussion about questions, challenges, and progress already made in pursuing an "eSource" project.  Trisha Simpson of UCB and Amy Nordo of Duke discussed their respective work on eSource projects for the group, and several challenges awaiting projects in this area were discussed.  The attendees agreed that establishing a formal eSource Stakeholders Group was in everyone's best interest, and there is more to come on that front.