Difference between revisions of "Data Transparency"

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|[[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  
 
|[[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  
 
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|[[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
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|[[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
 
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|[[Policy 0070 Interpretations]]|| The PhUSE Data Transparency Working Group has been reviewing very closely Policy 0070 and its External Guidance. The Working Group is looking further into different aspects of the policy and aim at providing further guidance and interpretations where needed. || Yes
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|[[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
 
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|[[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
 
|[[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

Latest revision as of 09:26, 10 October 2019

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
Liz Roberts Project Lead UCB Liz.Roberts@ucb.com

Current Projects

Working Group Description Recruiting New Members
GDPR Impact on Data Collection Practices The goal of this project is to share experiences and approaches for collecting Date of Birth and other personal information in compliance with regulations. For example, the project will explore the impact of collecting minimal expected information on Date of Birth; by only collecting Year of Birth (collected) and Age (collected for derived) for standard clinical trials. The project will create a best practices white paper to summarise experiences and recommendations. The team has split into three sub teams; Data Collection and PII, Safeguard and Processes and Data Breach. Yes
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


Webinar Presentations

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

Presentations

US CSS 2018