| 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 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 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 Leads | |
|---|---|
Lauren Hepburn (Iconic) | |
Abby McDonell (Privacy Analytics) | |
| Paula Rowley (PHUSE Project Assistant) | paula@phuse.global |
| Objectives & Deliverables | Timelines |
|---|---|
| Good Transparency Practices guidance document | Q3 2022 |
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|---|---|---|---|---|---|---|
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| Project Members | Organisation |
|---|---|
| Abhinav Srivastva | Exelixis |
| Andre Molgat | Health Canada |
| Benjamin C Shim | Eli Lilly |
| Brenda Tiffin | Claritidox |
| Cara Campora | Beigene |
| Devaki Thavarajah | Industry |
| Dhiraj Dabhi | Eli Lilly |
| Mahesh Swaminathan | Bristol Myers Squibb |
| 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 |