Abstract

Metadata is now an integral part of the clinical trial process. CDISC provides the framework for this metadata and Define.xml provides a way to share the final product. There is, however, no standard way to efficiently collect, manage and collaborate in the process of creating metadata.

Clinical Metadata provides an end-to-end metadata management solution, including CDASH, SDTM, ADaM and output metadata. It generates SAS code fragments and submission deliverables, automating repetitive programming tasks, accelerating and simplifying the development process. Clinical Metadata is built as a web-based single page application, using the latest technologies and practices, and is securely hosted in the Amazon Web Services cloud. Its visualisation tools present the user with a high-level metadata overview and allows them to drill down into individual metadata fragments. In-built standards management, traceability and impact analysis tools help users understand the relationships between each metadata element as well as encourage Agile and collaborative ways of working.

PhUse Conference

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