CDISC SHARE – Pathway into the Future for Standards Development & Delivery

 

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ABSTRACT:

Over the past decade, CDISC has fulfilled its mission by publishing and supporting a suite of standards across the research study lifecycle and data chain from collection (CDASH standard) through regulatory submission (SDTM standard) and analysis (ADaM standard).  More recently, these standards have been complemented and further aligned through standard controlled terminology hosted by the National Cancer Institute.  As global adoption of these standards increases, CDISC wishes to build on this success by providing a “1-stop shopping” environment where CDISC data models, standard data elements and controlled terminology can be aligned, linked and published for electronic access and download. This environment, known as CDISC SHARE, is envisioned as a globally accessible electronic library, which through advanced technology, enables precise and standardized data element definitions to be used by applications and studies to improve biomedical research and its link with healthcare.

A detailed stakeholder analysis revealed that CDISC SHARE will reduce barriers to adoption, enabling organizations to consistently implement a single reference standard across the organization. The creation of a library of shared semantics will enable CDISC stakeholders – global biopharmaceutical companies, academic institutions and clinical research organizations – to achieve multiple benefits including improved operational efficiency around the collection, processing, exchanging and reporting of data, evaluation of drug safety concerns across traditional organizational boundaries, and, in the end, enhanced scientific capabilities and resulting patient benefits and therapeutic efficacies.

In parallel with the development of SHARE, CDISC is optimizing its standards development processes in order to develop and deliver new standards and disease-specific content more quickly. When CDISC SHARE goes live in late 2010, these new standards will be loaded and aligned with existing standards.

Regarding this new multi-dimensional metadata driven approach to standards development, this presentation describes:

-CDISC SHARE Project Background
-Development Partners
-Current Status & Next Steps
-Overview of Disease Projects
-Steps to Accelerate and Improve Standards Development


04/21/2010