| 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
| Problem 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
| Problem 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, ICON | lauren.hepburn@iconplclhepburn@privacy-analytics.com | ||
Abby McDonell, Privacy Analytics | Sarah Balay | shewitt@privacy||
Lauren White, PHUSE Senior Project Coordinator | |||
| Objectives & Deliverables | Timelines | ||
| Define the full set of requirements for GTP | Q32021 | ||
| Preparation of components of GTP | Q42021
| ||||||
|---|---|---|---|---|---|---|
| Project approved. | ||||||
Q1 2024 | ||||||
|
| Objectives & Deliverables | Timelines |
|---|---|
| Good Transparency Practices guidance document | Q2 2023 |
| Project Members | Organisations |
| Benjamin C Shim | Eli Lilly |
| Brenda Tiffin | Claritidox |
| Devaki Thavarajah | Industry |
| Mekhala Acharya | Takeda |
| Sarah Balay | Privacy Analytics |
| Sharon Niedecken | Pfizer |
| Shannon Lefaivre | Roche |
| Shweta Srivastava | Xogene | Sophia Zilber | Pfizer