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 anonymisation, 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.

In our new whitepaper, we discuss our approach to data anonymisation, including risk assessment, dataset validation considerations and a comparison between two processes for data de-identification.