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) |
| ||||||
---|---|---|---|---|---|---|
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 | Project Members | ||||||||||||||
Beate Hientzsch | Khaled El Emam | Sherry Meeh | |||||||||||||
Benoit Vernay | Kim Musgrave | Sven Greiner | |||||||||||||
Bharat Jaswani | Kishore Papineni | Thijs van den Hoven | |||||||||||||
Boris Grimm | Kristin Kelly | Vinitha Arumugam | |||||||||||||
Carl Herremans | Nancy Freidland | Cathal Gallagher | Nate Freimark | Gary Chen | Nick De Donder | Gene Lightfoot | Patricia Coyle | Hong Qi | Per-Arne Stahl | Jacques Lanoue | Ravi Yandamuri | Joanna Koft | Sarah Nolan | Kelly Mewes | Shafi Chowdury |