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Clinical trial data anonymisation and data sharing

A discussion of data sharing with research consortiums

In the last decade, EMA, FDA, Health Canada and others have issued numerous guidelines on sharing and publishing clinical trial data, to protect patient privacy.

At the same time, new data sharing entities, such as C-PATH, TCIA, and others have been established to accelerate the discovery and development of new treatments.

For sponsors and CROs, clinical trial transparency efforts, like medical writing redactions and data anonymization, sit squarely at the intersection of these developments.

Within this context, we provide our experiences in data anonymisation of SDTM datasets for a data sharing consortium.

Reserve your copy of our upcoming whitepaper, where we discuss our approach to data anonymization, including risk assessment, dataset validation considerations and a comparison between two processes for data de-identification.

Whitepaper

De-identification of SDTM datasets in the context of data sharing with research consortiums