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: 

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

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