FEATURED ARTICLES INVESTOR NEWSLETTER ISSUE N°3
FIRST QU FALL 2009
ARTER 2016
Breaking Out of Silos - Moving Toward End-to-End Standards Development Rhonda Facile, CDISC VP, Standards Development, and Barrie Nelson, CDISC VP, Standards, Technology & Technical Services
The need to connect, complete and harmonize standards has become a key area of focus for CDISC standards teams. At the end of last year, CDISC conducted a series of “Listening Tour” calls with nine CDISC member organizations. From these calls we learned that our members see the potential benefits of End-to-End (E2E) standards and that it is their long-term goal.
Before we get too far, let’s define what we mean by End-to-End Standards Development. We mean developing concept-based, complete metadata that is harmonized or consistent from protocol to collection to analysis and finally submission supported by consistent controlled terminology.
On the CFAST project, we have been testing an approach that has gradually built on SDTM to include CDASH and ADaM in some of the TA User Guides. Terminology was also included and follows a development process as does Questionnaires Ratings and Scales (QRS). But to really accomplish the goal of creating E2E standards for TAs, we need to build on, and use, systems CDISC has in place to support asynchronous and synchronous cross- team collaboration.
Typically, the CDISC foundational standards teams work independently on team-defined goals, effectively in team silos. Consequently, when we release new or updated standards they may be somewhat disjointed because we are not considering the standard holistically. This is not intentional; it’s just the way the teams have evolved over time. Sometimes we have to make adjustments or corrections to one of the published standards to accommodate requirements that were either not originally considered, or emerged later from one of the other standards. Going forward, we would like to foster a more collaborative project-based approach to standards development, aligned with the CDISC Roadmap. Project teams will be made up of representatives of the relevant foundational teams (CDASH, SDS, ADaM, CT, SEND, XML Tech) and will work on harmonized cross-standard solutions that will eliminate or minimize the need for any later remediation. This will not eliminate the need for team-focused goals, such as maintenance activities and education, but this will help us move toward a holistic “CDISC Standard” where the constituent parts (Foundational and TA standards) are more aligned, talk to each other and better support semantic interoperability.
During the CDISC IntraChange, held 16-18 March, steps were taken in this direction by allowing maximum time for cross-team sessions and focusing on closing known gaps and open topics. Other goals were to explore ways to streamline governance across all development, ensuring that CDISC can continue to move effectively toward cross-project standards development, while maintaining all published CDISC standards. We acknowledge that to develop high quality standards we need the full participation of experts on all standards development teams.
We are well positioned to take these steps now. We have the tools (SHARE) and experience from both the Foundational and Therapeutic Area teams to move effectively in the direction of end-to-end standards.
Please visit the CDISC website for more information and updates on the Foundational Standards, Therapeutic Area Standards, and CDISC SHARE.
CDISC CDIS CDI C WEBSIT LINK WEBSITE LINK 4
liin
lliin
liin lliin
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22