cdisc术语 - drug information association.ppt

* Frank * Controlled Terminology represents one of CDISC’s broadest and most ambitious initiatives. We formalized… Primary Objective…across the clinical trial continuum from the point of data collection through to eSubmissions * The Enterprise Vocabulary Service of the National Cancer Institute has committed significant resources and is making a significant investment in the CDISC Terminology Initiative. This is of tremendous value to CDISC, as it allows us to leverage their rich knowledge and expertise in the area of Terminology Development and Production. When we first kicked-off the CDISC Terminology Initiative in 2005 we identified a set a key working principals (or key objectives) to help guide terminology development. I am pleased to say these guiding principals still hold true today. The first objective is to “define and support terminology development across all CDISC standards” The initial scope of work here centered around defining terminology for the SDTMIG. … Since we are a standards org, we need to be sure we are consistent and standardized throughout the org and across all the various CDISC teams…The CDISC Technical Roadmap Finally, we want to “Ensure a harmonized approach…” (NCI, FDA, SDOs) Harmonization is a recurring theme that you will be hearing, because it is a critically important component of standards development. It is the harmonization aspect that will ultimately determine the interoperability and usability of the standards we develop. Standards development in isolation does not work… As with all CDISC standards… In looking for a Terminology partner there was only one organization that met these important criteria. * * * * End of Shannon’s section Copyrighted material - not to be duplicated. * Frank * Frank * * Frank * Frank * * Content vs. terminology vs. transport standards * Content vs. terminology vs. transport standards * * Frank This slide gives an example of data that is not in a standard format and not described i