Project |
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Scope |
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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 |
preserves 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 |
as 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
Problem Statement |
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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
Problem Impact |
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Good Transparency Practices (GTP) would provide a means to achieving accountability and traceability while providing reasonable assurance that privacy requirements are being upheld. |
Project Leads | |||
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Lauren Hepburn, ICON | lauren.hepburn@iconplclhepburn@privacy-analytics.com | ||
Abby McDonell, Privacy Analytics | Sarah Balay | shewitt@privacy||
Paula Rowley (PHUSE Project Assistant) | paula@phuse.global | ||
Objectives & Deliverables | Timelines | ||
Define the full set of requirements for GTP | Q32021 | ||
Lauren White, PHUSE Senior Project Coordinator | Preparation of components of GTP | Q42021
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Group are completing current background research and organising notes to prepare for writing the GTP guidance. | ||||||
Q1 2024 | ||||||
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Objectives & Deliverables | Timelines |
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Good Transparency Practices guidance document | Q2 2023 |
Project Members | Organisation |
Abhinav Srivastva | Exelixis |
Benjamin C Shim | Eli Lilly |
Brenda Tiffin | Claritidox |
Cara Campora | Beigene |
Devaki Thavarajah | Industry |
Manohara Basoor Halasiddappa | Algok Bio |
Mekhala Acharya | Takeda |
Sanjay Bagani | Xogene |
Sarah Balay | Privacy Analytics |
Sharon Niedecken | Pfizer |
Shannon Lefaivre | Roche |
Shweta Srivastava | Xogene |
Sophia Zilber | Pfizer | Rama Empati | Astrazeneca