The POSCH data processing experience. The problem of metadata.

Metadata, the term, may be new but metadata, the concept, is not new. For purposes of this paper, the term metadata is defined as the data used to define, store, retrieve, combine, analyze, and present the data values (the "real" data, so to speak). As clinical research studies get larger, it becomes desirable to use automated managers of the metadata. The Program on the Surgical Control of the Hyperlipidemias (POSCH), a national multiclinic clinical trial, manages most of its metadata manually but has been experimenting with ways to more fully automate them. Its Information Management System (IMS) is described with special emphasis on how it manages the metadata. The case is presented for further automation and standardization of metadata in large clinical research studies so that costs can be contained and smaller increments of "progress" can be measured. The concept of a Metadatabase Management System (MDBMS) is developed and illustrated using POSCH.