| Scope |
|---|
This project reviews on a regular basis a number of deliverables produced by other key stakeholders in the form of guidance, policies and articles. In particular, the PHUSE Data Transparency Working Group was invited to the EMA Policy 0070 Stakeholders meetings to comment on earlier version of the External Guidance.In addition, the Working Group has had a collaboration with TransCelerate on the topic and the 2 organisations provided each other comments on respective deliverables.The Working Group also provided comments to Health Canada on their respective policy and guidance that were available for public review. The Working Group had an opportunity to provide feedback to the Cochrane organisation on their paper 'Interim guidance on how to decide whether to include clinical study reports and other regulatory documents into Cochrane reviews'. |
| Project Leads | |
|---|---|
Jean-Marc Ferran | jmf@qualiance.dk |
Key Milestones
| Objective | Timeline |
|---|---|
Suggestions to EMA Policy 0070 Re-start | Completed – January 2020 |
| Clinical Data Summary Report Pilot Program Review | Completed – June 2019 |
CURRENT STATUS
There are no current reviews taking place at the moment.
Project Members
| For each deliverable to be reviewed, different working group members volunteer based on their interest. We do not try to align all the comments, although all comments are discussed within the group of reviewers and we provide all comments that are received from different experts so that the authors can receive and assess different opinions. |