Data Transparency

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).

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. 

DISCLAIMER

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 White Papers page on the PhUSE website. 

 

Click here to contact the Working Group.

Current Projects

GDPR Impact on Data Collection Practices

The goal of this project is to share experiences and approaches for collecting date of birth and other personal information in compliance with regulations. For example, the project explores the impact of collecting minimal expected information on date of birth by only collecting year of birth (collected) and age (collected for derived) for standard clinical trials. The project will create a best practices white paper to summarise experiences and recommendations. The team has split into three sub-teams: Data Collection and PII, Safeguard and Processes and Data Breach.

PhUSE De-identification Standards 

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.

Clinical Trials Data Transparency Toolkit

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.

Policy 0070 Interpretations

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

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.

Data De-identification Toolkit

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

 

For more information about this Working Group, please contact the PhUSE Office at workinggroups@phuse.eu.

 

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PhUSE is an expanding, global society with a membership of more than 9,250 clinical data scientists. It requires a large pool of resources to help with its running, and so there are many opportunities for members to become involved. Whether it's chairing a conference, presenting at an event, leading a working group or contributing to the quarterly online newsletter, we are always keen to hear from volunteers.

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