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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

Email

Beate Hientzsch

beate.hientzsch@mainanalytics.de

Lauren White (PHUSE Project Coordinator)

lauren@phuse.global





Status
colourBlue
titleCurrent 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)

PHUSE De-Identification Standard for SDTM 3.2, 2015

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)

PHUSE Data De-identification Standard for CDSIC ADaM 2.1 IG 1.0, and Updates for SDTM IG 3.2, Sherry Meeh, Johnson & Johnson, 2017

Data De-Identification Standard for SDTM 3.2 – Appendix 2: Low Frequencies Version 1.0 

Project Members 

Beate HientzschKhaled El Emam Sherry Meeh

Benoit Vernay

Kim MusgraveSven Greiner

Bharat Jaswani

Kishore PapineniThijs van den Hoven

Boris Grimm

Kristin Kelly

Vinitha Arumugam

Carl Herremans

Nancy Freidland

Cathal Gallagher

Nate Freimark

Gary Chen

Nick De DonderGene LightfootPatricia CoyleHong QiPer-Arne StahlJacques LanoueRavi YandamuriJoanna KoftSarah NolanKelly MewesShafi Chowdury