Status: Planned First registered on: 21/09/2020
Last updated on: 22/09/2020
1. Study identification
EU PAS Register NumberEUPAS37273
Official titleBackground rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines
Study title acronymACCESS-BGR
Study typeObservational study
Brief description of the studyThis study aims to generate background rates of adverse events of special interest for monitoring of COVID-19 vaccines, in 10 healthcare databases in 7 European countries
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsUMCU
Department/Research groupJulius Global Health
Organisation/affiliationUniversity Medical Center Utrecht
Website/Homepagewww.umcutrecht.nl
Details of (Primary) lead investigator
Title Dr
Last name Dodd
First name Caitlin
Is this study being carried out with the collaboration of a research network?
Yes
European PE & PV network
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?12

ARS
University of Bordeaux, France
SoSeTe, Italy
Countries in which this study is being conducted
International study

Denmark
France
Germany
Italy
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed19/05/2020
Start date of data collection01/10/2020
Start date of data analysis16/11/2020
Date of interim report, if expected15/12/2020
Date of final study report29/01/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherEuropean medicines Agency100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Dodd
First name Caitlin
Address line 1Heidelberglaan 100
Address line 2 
Address line 3 
CityUtrecht 
Postcode 
CountryNetherlands
Phone number (incl. country code)31887555555 
Alternative phone number 
Fax number (incl. country code) 
Email address c.n.dodd@umcutrecht.nl
Public Enquiries
Title Dr 
Last name Dodd 
First name Caitlin 
Address line 1Heidelberglaan 100 
Address line 2 
Address line 3 
CityUtrecht 
Postcode 
CountryNetherlands 
Phone number (incl. country code)31887555555 
Alternative phone number 
Fax number (incl. country code) 
Email address c.n.dodd@umcutrecht.nl 
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