Registration of COVID-19 related studies in the EU PAS Register

Registration of COVID-19 related studies in the EU PAS Register

In order to support the sharing of information on performed or planned studies and increase the efficiency of research, the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) and the European Medicines Agency (EMA) strongly encourage all researchers to register their pharmacoepidemiological studies related to the Covid-19 pandemic in the EU PAS Register available on the ENCePP website through the following link: http://www.encepp.eu/encepp/studiesDatabase.jsp

Researchers are also encouraged to upload and make public the study protocol with a description of the data collected or planned to be collected in order to facilitate and speed-up the design of observational studies by others.

In order to facilitate the retrieval of studies related to the Covid-19 pandemic, investigators should include the term “COVID-19” in the study title. Using this term in the field “Title of Study” of the search function will allow retrieval of all registered studies related to the pandemic.

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP®) is a network coordinated by the European Medicines Agency (EMA). The members of this network (the ENCePP partners) are public institutions and contract and research organisations (CROs) involved in research in pharmacoepidemiology and pharmacovigilance. Research interests are not restricted to the safety of medicines but may include the benefits and risks of medicines, disease epidemiology and drug utilisation. TEDDY Health data Working Group is involved, in collaboration with the Working Group 3 ‘Data Sources and Multi-source Studies’ of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), in the revision and analysis of Post-Authorisation studies in paediatric population included in the EU PAS Register.

More information are available at this link.

May 4th, 2020|