Clinical Practice Research Datalink (CPRD)
This sponsor has funded 1 studies across 3 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 31879 | Finalised | Ability of primary care health databases to assess medicinal products discussed by the European Union Pharmacovigilance Risk Assessment Committee... | No | No |
PAS by Risk Management Plan (RMP) requirement
Clinical Practice Research Datalink (CPRD)
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
Clinical Practice Research Datalink (CPRD)
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
Clinical Practice Research Datalink (CPRD)
3 Study countries specified are the following:
- France
- Germany
- United Kingdom