Project ScopeThere 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
Objective | Timeline |
---|---|
| ||||||
---|---|---|---|---|---|---|
PHUSE De-Identification Standard for ADaM 1.0 under construction |
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 | Hong Qi | |
Cathal Gallagher | Nate Freimark | ||
Gary Chen | Nick De Donder | ||
Gene Lightfoot | Patricia Coyle | ||
Jacques Lanoue | Per-Arne Stahl | ||
Jennifer ChinHong Qi | Ravi Yandamuri | ||
Joanna Koft | Sarah Nolan | ||
Kelly Mewes | Shafi Chowdury |