Data Transparency

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Working Group Overview

Over thirty 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 recently started to address aspects of GDPR that are relevant for the conduct of clinical trials.The Working Group also reviews on a regular basis draft deliverables or guidance from regulatory bodies (e.g. EMA, Health Canada), other industry organizations (e.g. TransCelerate) and also Academia (e.g. Cochrane).

Leadership Team

Current Leadership Team

Name Role Organization E-mail
Jean-Marc Ferran Project Lead PHUSE jean-marc.ferran@phuse.eu

Current Projects

Working Group Description Recruiting New Members
Clinical Trials Data Transparency Toolkit This project is exploring the evolving global landscape of clinical trial transparency and will showcase the existing and emerging global requirements and best practices relating to clinical study submission requirements. The team have three deliverables which they plan to produce in 2018 that support one another. Yes
PHUSE De-Identification Standards There are current efforts by regulators and sponsors to make Clinical Study Reports (CSR) and Individual Patient Data (IPD) from clinical trials shared more widely. The PHUSE De-Identification Project work on defining de-identification standards for CDISC standards and released in 2015 the PHUSE De-Identification standard for SDTM 3.2. The goal is to define standards to reduce efforts for companies to de-identify IPD and provide consistent data to researchers where data utility is considered. Yes
Policy 0070 Interpretations The PHUSE Data Transparency Working Group has been reviewing very closely Policy 0070 and its External Guidance. The project is looking further into different aspects of the policy and aim at providing further guidance and interpretations where needed. Yes
Policy, Guidance and Material Reviews The PHUSE Data Transparency Working Group, as an active player in the field, reviews on regular basis a number of deliverables produced by other key stakeholders in the form of guidances, policies or articles. Yes
Data De-identification Toolkit This project aims at providing practical guidance with regards to implementing data de-identification methods Yes
Terminology Harmonisation in Data Sharing and Disclosure Deliverables Currently there is inconsistency in terminology used in the field of data sharing and discolosure. These inconsistencies exist across industry and regulatory agencies as well as within PHUSE and cause unecessary confusion. This project aims to collect, align and standardize terminology and their definitions used in to be used in future PHUSE deliverables. Yes



Webinar Presentations

Data Transparency EU CSS Update 28-6/17
Data Transparency CSS 2018 Webinar April 25th 2018

Presentations

US CSS 2018