Study identification

PURI

https://redirect.ema.europa.eu/resource/50430

EU PAS number

EUPAS40404

Study ID

50430

Official title and acronym

Cohort monitoring of Adverse Events of Special Interest and COVID-19 diagnoses prior to and after COVID-19 vaccination (ECVM)

DARWIN EU® study

No

Study countries

Italy
Netherlands
Spain
United Kingdom (Northern Ireland)

Study description

This 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

Study status

Finalised
Research institution and networks

Institutions

Multiple centres: 6 centres are involved in the study

Networks

Contact details

Miriam Sturkenboom

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

Early-COVID-Vaccine-Monitorprotocol_EHRdatav0.2_20210331

English (663.74 KB - PDF)View document
Updated protocol

Early-COVID-Vaccine-Monitorprotocol_EHRdatav1.5 CLEAN

English (1.36 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable