The overall process of protecting the privacy of data subjects, including clinical study participants, and reducing the risk of re-identification by

  • modifying (e.g. suppressing, obscuring, aggregating, altering) identifiable information in structured data and documents
  • assessing and controlling the residual risk of re-identification
  • considering the context of the data release.

Definition adapted from PHUSE Terminology Harmonisation in Data Sharing and Disclosure Terms and Definitions (version 2) https://advance.phuse.global/pages/viewpage.action?pageId=10878987

 


Courtesy of TransCelerate project (https://www.transceleratebiopharmainc.com)Case study