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).
Working Group Lead
Jean-Marc Ferran is an Independent Consultant based in Copenhagen with more than 15 years of experience in the Life Sciences industry. Prior to starting his company, Qualiance, he worked as a Statistician, Standards Manager and Director of Statistical Programming at Novo Nordisk and Ferring Pharmaceuticals. Jean-Marc has led the PHUSE Data Transparency Working Group since 2014 and is an appointed member of the EMA Technical Anomymisation Group and Health Canada Stakeholder Reference Group on Public Disclosure of Clinical Documents. Jean-Marc also chaired the PHUSE Annual Conference in 2012 in Budapest, was a Director on the PHUSE Board from 2014 -2017, and is a Lifetime Honorary member of the society for his significant contribution to the organisation over a number of years.