| 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. |
| 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. |
| 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 |
Abby McDonell, Privacy Analytics |
Lauren White, PHUSE Senior Project Coordinator |
|
|---|
Q1 2024 |
|---|
|
| Objectives & Deliverables | Timelines |
|---|---|
| Good Transparency Practices guidance document | Q2 2023 |