Data Transparency

Since its inception, PhUSE has been an advocate of sharing and exchange of knowledge.

In this new era of data transparency and sharing data with researchers, healthcare companies are defining their processes and de-identification guidance in order to comply with data privacy regulations. In particular, it is possible for researchers to request access to data across sponsors.  A combination of the difference of company's data models and de-identification techniques may make the analyses cumbersome and error-prone.

Over twenty participants from Pharmaceuticals, CROs, Software and Academia, as well as CDISC and Data Privacy experts, have collaborated to define a set of rules built around the CDISC SDTM standards  to provide the industry with a consistent approach to data de-identification and increase consistency across anonymized datasets.

Each of the domains and variables that can potentially hold "Personally Identifying Information" (PII) are: 

  • Rated in terms of impact on data privacy, 
  • Allocated rules to apply, and 
  • The rationale and impact on data utility is recorded.

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

Project Update: December 2016

  • The goal is to finalise within the first part of 2017, what we progressed in 2016:
  • DeID standard for ADaM including examples from certain TA's
  • Update of the offset algorithm to also address imputed dates in ADaM
  • Blog / Paper on Policy 0070
  • Include feedback from users based on the questionnaire in deliverables and strategy
  • There will likely be a face-to-face meeting on 19th - 20th June 2017 at the EU CSS in London

Further information will follow in Q1

Current Projects 

For more information about this initiative, please contact the PhUSE Office (

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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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