PhUSE De-Identification Standards
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 & Members
|Beate Hientzsch||Benoit Vernay||Bharat Jaswani||Boris Grimm|
|Carl Herremans||Cathal Gallagher||Gary Chen||Gene Lightfoot|
|Jacques Lanoue||Jennifer Chin||Joanna Koft||Kelly Mewes|
|Khaled El Emam||Kim Musgrave||Kishore Papineni||Kristin Kelly|
|Nancy Freidland||Nate Freimark||Nick De Donder||Patricia Coyle|
|Per-Arne Stahl||Ravi Yandamuri||Sarah Nolan||Shafi Chowdury|
|Sherry Meeh||Sven Greiner||Thijs van den Hoven||Vinitha Arumugam|
- PHUSE De-Identification Standard for ADaM 1.0 under construction
Objectives and Timelines
- Date offsetting appendix updated to address the case of imputed dates in Analysis Dataset (e.g. ADaM).
- Looking for project lead to conduct the update of the PHUSE De-identification Standard for SDTM 3.3.
- PhUSE De-Identification Working Group:Providing De-Identification Standards to CDISC Data Models, Ferran et al., PhUSE Conference DH01 2015
- Data De-Identification Made Simple, Jørgen Mangor Iversen,LEO Pharma, PhUSE Conference DH02 2016
- 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
- EMA Policy 0070 External Guidance
- De-identification Guidelines for Structured Data, information and Privacy Commissioner of Ontario
- De-Identification and and Anonymization of Individual Patient Data in Clinical Studies, TransCelerate, 2016
- Practical Applications of Secure Computation for Disclosure Control, Luk Arbuckle, Khaled El Emam, 2016
- Protecting patient privacy when sharing patient-level data from clinical trials, Tucker et al, 2016