More than 30 participants from pharmaceuticals, CRO’s, 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 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 documents from regulatory bodies (eg, the EMA, Health Canada), as well as other industry organisations such at TransCelerate, and academia (eg, Cochrane).
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