Safer and Faster Evidence-based Translation (SAFE-T)
This sponsor has funded 1 studies across 1 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 3145 | Ongoing | Identification of drug-induced liver injury (DILI) cases in Spain, a national DILI registry (Spanish DILI Registry) | No | No |
PAS by Risk Management Plan (RMP) requirement
Safer and Faster Evidence-based Translation (SAFE-T)
The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.
Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.
PAS by study status
Safer and Faster Evidence-based Translation (SAFE-T)
The study status is defined according to the timeline dates specified.
Planned studies have not collected any data yet.
Ongoing studies collect data and should publish protocols as soon as possible.
Finalised studies should publish results in the first two weeks after finalisation.
Countries
Safer and Faster Evidence-based Translation (SAFE-T)
1 Study countries specified are the following:
- Spain