Data Transparency

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).