Difference between revisions of "PhUSE De-Identification Standards"

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= Project Overview  =
 
= Project Overview  =
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.
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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.
  
 
= Project Leads & Members =
 
= Project Leads & Members =
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= Project Updates =
 
= Project Updates =
*PhUSE De-Identification Standard for ADaM 1.0 under construction
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*PHUSE De-Identification Standard for ADaM 1.0 under construction
  
 
= Objectives and Timelines =
 
= Objectives and Timelines =
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= Project Activities =
 
= Project Activities =
 
*[https://www.phuse.eu/documents//working-groups/dt/phuse-deid-standard-sdtm-32-appendix-1-date-offsetting-v200-19889.pdf Date offsetting appendix updated to address the case of imputed dates in Analysis Dataset (e.g. ADaM)].
 
*[https://www.phuse.eu/documents//working-groups/dt/phuse-deid-standard-sdtm-32-appendix-1-date-offsetting-v200-19889.pdf Date offsetting appendix updated to address the case of imputed dates in Analysis Dataset (e.g. ADaM)].
*Looking for project lead to conduct the update of the PhUSE De-identification Standard for SDTM 3.3.
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*Looking for project lead to conduct the update of the PHUSE De-identification Standard for SDTM 3.3.
  
 
=Deliverables=
 
=Deliverables=

Latest revision as of 09:25, 10 October 2019


Project Overview

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.

Project Leads & Members


Name
Beate Hientzsch Benoit Vernay Bharat Jaswani Boris Grimm
Carl Herremans Cathal Gallagher Gary Chen Gene Lightfoot
Jacques Lanoue Jennifer Chin Joanna Koft Kelly Mewes
Khaled El Emam Kim Musgrave Kishore Papineni Kristin Kelly
Nancy Freidland Nate Freimark Nick De Donder Patricia Coyle
Per-Arne Stahl Ravi Yandamuri Sarah Nolan Shafi Chowdury
Sherry Meeh Sven Greiner Thijs van den Hoven Vinitha Arumugam
Hong Qi


Project Updates

  • PHUSE De-Identification Standard for ADaM 1.0 under construction

Objectives and Timelines

Objective Timeline

Project Activities

Deliverables

Papers

Referenced In

Archived Content