Status: Planned First registered on: 01/04/2021
Last updated on: 07/05/2021
1. Study identification
EU PAS Register NumberEUPAS40404
Official titleCohort monitoring of Adverse Events of Special Interest and COVID-19 diagnoses prior to and after COVID-19 vaccination
Study title acronymECVM
Study typeObservational study
Brief description of the studyThis study will monitor AESI prior and following COVID-19 vaccination, with the purpose to estimate the incidence rates and pick up signals. This study will be conducted with funding from the EMA and in 4 data sources that have access to COVID-19 vaccine data and are able to rapidly update their data
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 groupData Science & Biostatistics
Organisation/affiliationUniversity Medical Center Utrecht
Website/Homepagewww.umcutrecht.nl
Details of (Primary) lead investigator
Title Professor
Last name Sturkenboom
First name Miriam
Is this study being carried out with the collaboration of a research network?
Yes

EU PE &PV
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?6

ARS
Countries in which this study is being conducted
International study

Italy
Netherlands
Spain
United Kingdom (Northern Ireland)
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/12/2020
Start date of data collection15/02/2021
Start date of data analysis30/03/2021
Date of interim report, if expected
Date of final study report30/11/2021
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
OtherEMA100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Sturkenboom
First name Miriam
Address line 1Heidelberglaan 100
Address line 2 
Address line 3 
CityUtrecht 
Postcode 
CountryNetherlands
Phone number (incl. country code)31657831983 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Professor 
Last name Sturkenboom 
First name Miriam 
Address line 1Heidelberglaan 100 
Address line 2 
Address line 3 
CityUtrecht 
Postcode 
CountryNetherlands 
Phone number (incl. country code)31657831983 
Alternative phone number 
Fax number (incl. country code) 
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