Skip navigation

Articles

 

 

Christiansen D, Kubick W. The CDISC metadata model; November 26, 2001.

 

The CDISC Submission Data Standards Metadata Approach

 

The CDISC Submission Data Model has focused on the use of effective metadata as the most practical way of establishing meaningful standards applicable to electronic data submitted for FDA review. Metadata is defined as “data about the data”; in other words, metadata includes description of the content, context, structure, and/or purpose of a database. It is important to recognize that the metadata provided by the model is intended to be the minimum required to meet the need of FDA users, and is not intended to fully meet all of the needs of the sponsor’s data management, statistics, or other internal groups. Additional internal metadata standards will be desirable within most organizations to govern the ways that data is captured, cleaned, and analyzed statistically. Available through the following link, click here.