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Processing Retrospective Data in Clinical Research


One of the most demanding challenges in clinical research is to establish a clear framework for the lawful and ethical use of retrospective data.

Retrospective data represents a valuable source of information for research projects; however, it is typically collected for purposes unrelated to the research’s objectives. This gives rise to concerns such as the potential for unlawful repurposing of personal data and the need to identify an appropriate legal basis.

The issue of how to regulate the processing of retrospective data has been a central concern for our WLC experts working in Bio-Streams. The Bio-Streams initiative adopts a data-driven approach to combat childhood obesity and endeavors to create the first EU-wide virtual biobank dedicated to obesity in young individuals. Within this context, WLC assumes the responsibility of guiding Project Partners in adhering to pertinent data protection laws and regulations.

This report offers a structured framework designed to aid Project Partners in navigating, among other things, the complexities of managing retrospective data. It serves as a valuable resource for identifying the most suitable solutions to conduct their research activities while ensuring compliance with legal and ethical standards.

For more detailed insights into our analysis of retrospective data in clinical research contexts, please consult the document available here: BioStreams – Report on Data Management Policy.

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