Abstract: Systems and methods for processing metadata associated with a clinical trial are described. In one aspect, a computing device receives collected data with embedded metadata. The device extracts the embedded metadata, and accesses a database to determine characteristics of the embedded metadata. The device then accesses protocol rules where the protocol rules are a set of data collection requirements and procedures for a given clinical trial. The device ensures compliance of the embedded metadata by comparing the characteristics of the embedded metadata with the protocol rules. The device then reports the compliance or non-compliance of the collected data.

Abstract: The centralized collection of geographically distributed data is accomplished using a system which takes advantage of an interactive programming language, such as JAVA™ and existing wide area networks, such as the Internet including the world wide web (4), to collect high quality data in an information center (10). The information center being connected to remote sites (1) through the wide area network. One or more levels of validation of the data prior to storage in a database is provided for.