Project Scope

There are current efforts by regulators and sponsors to make Clinical Study Reports (CSR) and Individual Patient Data (IPD) from clinical trials shared more widely. The PHUSE De-Identification Project work on defining de-identification standards for CDISC standards and released in 2015 the PHUSE De-Identification standard for SDTM 3.2. The goal is to define standards to reduce efforts for companies to de-identify IPD and provide consistent data to researchers where data utility is considered.