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.
For more information about this initiative,
please contact the PhUSE Office (firstname.lastname@example.org).