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What’s New with CDISC Standards?

Progress on CDISC Standards has come at a quickened pace in recent years. Helping make advancement of industry-wide standards possible is collaboration among CDISC and other participating organizations (Critical Path Institute, Association of Clinical Research Organizations, Innovative Medicines Initiative, and National Cancer Institute). Joining in the collaboration are regulatory authorities and the pharma industry itself, as well as TransCelerate Biopharma which continues to press forward with its standards initiative.

CDISC Standards Briefing

As success stories flow into US FDA, EMA, and PMDA, whether or not CDISC Standards would take hold, is no longer a question. Today numerous industry standards are available for use in your own clinical trials. There are foundational standards for Planning, Data Collection, Data Tabulations, and Analysis. Under these are XML Data Exchange Standards. There are also standards that account for Therapeutic Area Products as well as Healthcare Link Products. From there we have a whole set of Semantics that comes with its own Glossary, Controlled Terminology, and BRIDG.  Underlying it all is CDISC SHARE.

Staying on top of the status of every standard and new ones in development can be a real challenge. To help data mangers and other trial professionals sort it all out, I held a recent webinar. It was timed to follow the CDISC Interchange held in November, giving anyone unable to attend that conference an opportunity to hear what they missed and learn what to keep in mind when preparing for upcoming submissions.

Trial Data Standards and Ebola

The Annual CDISC Interchange grows every year and indeed the 2014 event was the largest and well-attended yet. During the Interchange, core teams met and worked on their respective standards. Conference attendees were able to choose from a number of CDISC classes.

One class I participated in explored healthcare initiatives surrounding the sharing of data for mining by others for the benefit of patients. Discussion included pulling of data from medical systems for use in clinical trials. Intellectual property was explored as a potential obstacle to research. Adding some context to the data sharing subject, we heard about work currently being done around Ebola and how CDISC Standards can help. We examined how looking at patient data while in the midst of a crisis − rather than retrospectively – offers potential new benefits.

Therapeutic Area Standards

One of the most exciting areas in the standard's world is the development of Therapeutic Area (TA) Standards. Now numbering in the double digits, another ten or so are expected to come in 2015. In the webinar a recap of currently available standards and those coming is provided, as well as an example of how TA Standards get implemented.

CDASH Users, Be Heard Now!

Clinical Data Acquisition Standards Harmonization commonly known as CDASH Standards were released in 2006. I had the pleasure of serving on the working group that developed them and continue to volunteer my time on these. Using CDASH Standards streamlines data collection and covers 16 core domains ranging from Adverse Events, Concomitant Medications, Demographics and Protocol Deviations, to Lab Test Results and Substance Abuse to name a few.

When obtaining CDASH Standards, you get definitions of all the domains and information indicating fields that must be converted to SDTM and this is all available from CDISC for FREE. With a paid CDISC membership you also get access to information and guidance to help with implementation, all for a nominal fee.

Presently the working group is soliciting feedback from CDASH users, making this an opportune time to voice your opinion. Should you find any information contained in the standards unclear, feel something needs to be re-worded, or even want to suggest a field to be added or removed, details on how to provide feedback can be found here: http://www.cdisc.org/cdash. Input and suggestions received through December 31 will be considered in the development of the latest CDASH version, expected to be issued in 2015.

Acronym Overload?

So many acronyms! CDISC SHARE, CFAST, PRM, SDTM, SEND, ADaM, XML, BRIDG, and Therapeutic Standards A to Z (or in this case, A to V: Alzheimer's to Virology). Need help making sense of it all?

Catch the webinar, now available to watch on-demand at your convenience. You'll get a one-hour crash course (FREE!) on CDISC Standards.

Here's what's covered in the webinar:

  • Regulatory Messages
  • State of Current Standards
  • Therapeutic Standards
  • CDISC Share
  • CDISC Partnerships
  • Future of CDISC

So tune in and gain some added perspective as you prepare for upcoming submissions. We'll also take a close-up look at the Diabetes Therapeutic Area Standard.

Have a CDISC Standards success story of your own? Share your experience and help spread the global language of clinical trials!

CDISC Standards Briefing: Get Ready for FDA Submissions

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