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 | |
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Beate Hientzsch | |
Lauren White (PHUSE Project Coordinator) |
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Project concluded. |
| Resources | |
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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 |