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 |
Key Milestones
Lauren White (PHUSE Project Coordinator) |
|
|---|
|
|---|
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) |
Bharat Jaswani
Boris Grimm
Kristin Kelly
Carl Herremans
Cathal Gallagher
Gary Chen
Project Members
Benoit Vernay
| Data De-Identification Standard for SDTM 3.2 – Appendix 2: Low Frequencies Version 1.0 |