Data Transparency

Over thirty 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 recently started to address aspects of GDPR that are relevant for the conduct of clinical trials.The Working Group also reviews on a regular basis draft deliverables or guidance from regulatory bodies (e.g. EMA, Health Canada), other industry organizations (e.g. TransCelerate) and also Academia (e.g. Cochrane).

The PhUSE De-Identification Working Group plans to work on defining de-identification standards for CDISC SDTM 3.2 and will extend their scope to other CDISC standards in the future. 

Click here to download the PhUSE De-identification Standard for SDTM 3.2

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 will explore 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 EMA to make Clinical Study Reports (CSR) and Individual Patient Data (IPD) from clinical trials shared more widely. The PhUSE De-Identification Standards Working Group have worked on defining de-identification standards for CDISC SDTM 3.2 and have recently reviewed the Health Canada Guidance document. The team will extend their scope to other CDISC standards in the future.

Clinical Trials Data Transparency Toolkit

This project is exploring 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 2018 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 aim at providing 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 regular basis a number of deliverables produced by other key stakeholders in the form of guidances, policies or articles.

Data De-identification Toolkit

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

 

For more information about this initiative, please contact the PhUSE Office (workinggroups@phuse.eu).

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PhUSE is an expanding, global society with a membership of more than 8,000 clinical data scientists. It requires a large pool of resources to help with its running so offers 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 newsletter, we are always keen to hear from volunteers.

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