Chapter 22


David H. Christiansen

22.1 Introduction

Metadata (also “meta data” or “metadata”) are commonly defined as “data about data.” Clinical trial metadata are concerned with describing data originating from or related to clinical trials, including data sets and statistical analyses performed on the datasets. Clinical trial metadata may be in the form of a separate written document, may be linked electronically to a document or data set, or may be integrated into a data set as part of the definition of the data fields or variables. Metadata may be accessed by statisticians performing analyses on the data and by other scientists reviewing or using the data and results. Increasingly, metadata included in computerized data sets (machine-readable metadata) can also be used by statistical software and other computer applications to present or use the data in an appropriate manner, based on the metadata description. For machine-readable metadata to be used by a computer application, standards for the format and content must exist for both the metadata and the application that reads the metadata. Metadata are an important component of the documentation required for regulatory submissions and should provide a clear and concise description of the data collected and the analyses performed.

22.2 History/Background

The term “metadata” was coined in 1969 by Jack E. Kelly. Although “Metadata” was copyrighted in 1986 by The Metadata Company [1], the generic “metadata” is commonly ...

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