Data De-identification and Anonymization of Individual Patient Data in Clinical Studies — A Model Approach

This paper from TransCelerate BioPharma Inc. considers how de-identification and anonymization techniques can be applied to individual patient data in order to fulfill transparency, disclosure and research requests while safeguarding the privacy of individuals (e.g., participants and company staff). This paper proposes which techniques to apply in order to conform to existing directives and regulatory guidance while balancing the utility of the de-identified data to the researcher.