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Project Scope

Define a set of best practices for data transparency and create a Good Transparency Practices guidance. The best practices will aim to ensure anonymised data is compliant with the legal requirements, as defined by regulators, as well as preserving as much data utility as possible. If possible, regulators such as the European Medicines Agency (EMA) and Health Canada will be consulted to ensure that the guidance created by the Working Group reflects their current standards. The planned document will have a similar format to the Good Clinical Practices guidance created by the International Conference on Harmonisation (ICH). The Good Transparency Practices document will include: an introduction, a glossary of terms, a set of principles and subsections dedicated to different parties involved in the anonymisation process (such as the trial sponsor and the entity performing the anonymisation), describing their responsibilities and providing guidance. Additional sections may be added as needed. 

Project Statement 

Transparency initiatives allow public scrutiny and research in the application of new knowledge based on clinical data. Current GxP guidelines do not apply to transparency as it represents a different flow of data in which anonymisation is carried out on a copy of the regulated data.

Project Impact

Good Transparency Practices (GTP) would provide a means to achieving accountability and traceability while providing reasonable assurance that privacy requirements are being upheld.


Project LeadsEmail

Lauren Hepburn

lhepburn@privacy-analytics.com

Sarah Balayshewitt@privacy-analytics.com
Lauren Whitelauren@phuse.global
Objectives & Deliverables Timelines
Define the full set of requirements for GTPQ32021
Preparation of components of GTPQ42021

CURRENT STATUSQ3/42021

Group are completing current background research and organising notes to prepare for writing the GTP guidance.


Project MembersOrganisations
Abhinav SrivastvaExelixis
Benjamin C ShimEli Lilly
Brenda TiffinClaritidox
Devaki ThavarajahIndustry
Manohara Basoor HalasiddappaAlgok Bio
Mekhala AcharyaTakeda
Sanjay Bagani Xogene 
Sarah BalayPrivacy Analytics
Sharon NiedeckenPfizer
Shannon LefaivreRoche
Shweta SrivastavaXogene 
Sophia ZilberPfizer


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