Study identification

PURI

https://redirect.ema.europa.eu/resource/50442

EU PAS number

EUPAS37273

Study ID

50442

Official title and acronym

Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines (ACCESS-BGR)

DARWIN EU® study

No

Study countries

Denmark
France
Germany
Italy
Netherlands
Spain
United Kingdom

Study description

This 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

Study status

Finalised
Research institution and networks

Institutions

Multiple centres: 12 centres are involved in the study

Networks

Contact details

Miriam Sturkenboom

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

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

ACCESS_BGRprotocolSept222020

English (1.31 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