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Project 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 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 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. |
Objectives & Deliverables | Timelines |
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Good Transparency Practices guidance document | Q3 2022 |
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- Group are completing current background research and organising notes to prepare for writing the GTP guidance.
- Successfully solicited involvement from the EMA and Health Canada.
- Group are beginning the first draft of GTP guidance.
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Project Members | Organisation |
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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 |