PHUSE De-identification Standards project

The PHUSE De-identification Standards project has defined de-identification standards for CDISC SDTM 3.2 and will extend its scope to other CDISC standards in the future. 


This set of de-identification rules defined for CDISC SDTM 3.2 is written with the goal of both facilitating the assessment of direct and quasi identifiers in SDTM datasets and ensuring consistency in anonymized data shared across sponsors.

The definitions of direct and quasi-identifiers and the decisions and concepts described in this deliverable represent the consensus of the working group rather than an endorsement of the companies represented in the working group.

However, the rules described here do not guarantee an acceptable or very small residual risk of re-identification in the data and it is the responsibility of the sponsors to define and measure what the residual risk is and define an acceptable risk threshold.

SDTM being also a normalized data model, not all direct nor quasi identifiers may be captured in this deliverable and it is the responsibility of the sponsor to ensure that such assessment is conducted and reviewed according to defined internal procedures.

To download the documents, please visit the PHUSE White Paper page on the website. 

Data Transparency

Working Group & Project Scope

Working Group Leads

Jean-Marc Ferran


More than 30 participants from pharmaceuticals, CROs, software and academia, as well as CDISC and data privacy experts, have collaborated on developing a data de-identification standard for SDTM (known as “the PHUSE de-identification standard”). Since then the project has expanded to address EMA Policy 0070 matters, create a Data Transparency Roadmap across jurisdictions and has recently started to address aspects of GDPR that are relevant for the conduct of clinical trials. The Data Transparency Working Group also reviews on a regular basis draft deliverables or guidance from regulatory bodies (e.g. the EMA, Health Canada), other industry organisations (e.g. TransCelerate) and academia (e.g. Cochrane).

Clinical Trials Data Transparency Toolkit

Liz Roberts

Anne Cutting


This project explores the evolving global landscape of clinical trial transparency and will showcase the existing and emerging global requirements and best practices relating to clinical study submission requirements. The team have three deliverables which they plan to produce in 2019 that support one another.

Data De-identification Toolkit

Jean-Marc Ferran

Lukasz Kniola

This project aims to provide practical guidance with regards to implementing data de-identification methods.

PHUSE De-identification Standards 

Beate Hientzsch

There are current efforts by regulators such as the EMA to make Clinical Study Reports (CSRs) and Individual Patient Data (IPD) from clinical trials shared more widely. The PHUSE De-identification Standards Working Group has worked on defining de-identification standards for CDISC SDTM 3.2 and has recently reviewed the Health Canada Guidance document. The team will extend its scope to other CDISC standards in the future.

Policy 0070 Interpretations

Jean-Marc Ferran

Lukasz Kniola

Sarah Nevitt

Rashmi Dodia

The PHUSE Data Transparency Working Group has been reviewing very closely Policy 0070 and its External Guidance. The Working Group is looking further into different aspects of the policy and aims to provide further guidance and interpretations where needed.

Policy, Guidance and Material Reviews

Jean-Marc Ferran

The PHUSE Data Transparency Working Group, as an active player in the field, reviews on a regular basis a number of deliverables produced by other key stakeholders in the form of guidance, policies and articles.

Terminology Harmonisation in Data Sharing and Disclosure Deliverables

Lukasz Kniola

Sarah Balay

Currently there is inconsistency in terminology used in the field of data sharing and disclosure. These inconsistencies exist across industry and regulatory agencies as well as within PHUSE and cause unnecessary confusion. This project aims to collect, align and standardise terminology and their definitions used in to be used in future PHUSE deliverables. Previous PHUSE deliverables as well as key publications in the field will be examined to create a proposal for a baseline list of terms and definitions to be used moving forward.




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