Hume, Samuel

English

Data quality is foundational to clinical research and each process through which the data passes must be documented such that the published tables and listings can be traced back to the original, raw data (Nahm, 2012). In regulated clinical research, traceability is a requirement and indicates that the content of the clinical study report can be traced back to the original source data. Today’s clinical research solutions have significant traceability limitations. This design science research (DSR) project creates a traceability framework for clinical research that builds on the existing industry data standards and improves a reviewer’s understanding of the data for data quality and regulatory compliance purposes. The framework consists of 3 layers: (1) the Information Product Map (IP-Map) model: a highlevel view of the manufacturing process for creating an information product (IP); (2) the CDISC standards metadata: metadata describing the IPs, data elements, and computations at a detailed level of granularity; and (3) a graph model: traceability throughout the clinical research data lifecycle that supports traceability visualization, validation, and queries. The primary benefits of the Trace-XML Framework are (1) to identify and resolve traceability gaps in clinical study metadata, (2) validate metadata traceability in a clinical study, and (3) query and visualize traceability metadata. The Trace-XML Framework maximizes the use of the existing standards models and technology to minimize barriers to implementation. This framework contributes a new extension to the industry standard metadata that addresses traceability gaps uncovered during the development of the Trace-XML software. The TraceXML software contributes the algorithms needed to remedy and validate traceability in the Trace-XML graphs, in addition to adding support for traceability queries

Beadle Scholar at Dakota State University

Enhancing Traceability in Clinical Research Data Through an Information Product Framework

https://scholar.dsu.edu/cgi/viewcontent.cgi?article=1308&context=theses

Enhancing Traceability in Clinical Research Data Through an Information Product Framework

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Beadle Scholar at Dakota State University