PHUSE De-identification Standards
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. |
Project Leads | |
|---|---|
Beate Hientzsch | |
Lauren White (PHUSE Project Coordinator) |
CURRENT STATUS |
|---|
Project concluded. |
| Resources | |
|---|---|
PHUSE De-Identification Working Group:Providing De-Identification Standards to CDISC Data Models, Ferran et al., PHUSE Conference DH01 2015 (Paper) (Presentation) | |
Data De-Identification Made Simple, Jørgen Mangor Iversen,LEO Pharma, PHUSE Conference DH02 2016 (Paper) (Presentation) | Data De-Identification Standard for SDTM 3.2 –Date offsetting appendix updated to address the case of imputed dates in Analysis Dataset (e.g. ADaM) |
| Data De-Identification Standard for SDTM 3.2 – Appendix 2: Low Frequencies Version 1.0 |