Working Group Scope |
Active since 2014 the Data Transparency Working Group is made up of more than 70 active members from pharmaceuticals, CRO’s, software and academia, as well as CDISC and data privacy experts. Team members have since collaborated on developing a data de-identification standard for SDTM (known as the ‘PHUSE de-identification standard’). Since then, the Working Group 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 (e.g. the EMA, Health Canada), as well as other industry organisations such as TransCelerate, and academia (e.g, Cochrane). In addition to the projects PHUSE have continued to strengthen its place as the world’s largest home for data transparency events, by sharing vital knowledge of the field and creating a space where questions can be asked, and challenges addressed. The events look to meet the ongoing needs of data transparency within the clinical development arena and features thought-provoking presentations, panel discussions and Q&A sessions from experts in the data sharing field. |
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devaki.thavarajah@phuse.global
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