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. |
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. |
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, Industry |
Abby McDonell, Privacy Analytics |
Lucy Marks, PHUSE Senior Project Coordinator |
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Q3 2024 |
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Objectives & Deliverables | Timelines |
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Good Transparency Practices guidance document | Q2 2023 |