Registry name: The European Union electronic register of post-authorization studies (EU PAS Register)
Year established: 2011
Country: European Union
Points of interest:
- The EU PAS Register is a publicly available register of non-interventional post-authorization studies, focused on observational research
- The register is controlled by the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
- ENCePP was established by the European Medicines Agency (EMA) and the EU regulatory network, with a goal to facilitate independent and transparent post-authorization monitoring of European medical products.
- Protocol registration and trial results disclosure for all studies initiated after July 2, 2012 is mandatory in the EU PAS for non-interventional post-authorization safety surveillance studies, non-interventional post-authorization efficacy studies, ENCEPP Seal studies, imposed non-interventional PASS (i.e., Category 1 and Category 2), and imposed non-interventional PAES
- It is recommended that protocol registration occur prior to study start
- In regards to a data sharing plan, the study questionnaire includes a question regarding sources of data, and the investigator is asked to provide a brief description of the data analysis plan. There is no obligation to disclose the data sharing plan as of the date that this blog article is published
Related transparency research/articles:
- An analysis of characteristics of post-authorization studies registered on the ENCePP EU PAS Register
- Reporting guiding for pharmacoepidemiological studies are urgently needed
- FAQ – EU PAS Register
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