Study identification

PURI

https://redirect.ema.europa.eu/resource/50439

EU PAS number

EUPAS39370

Study ID

50439

Official title and acronym

Coverage of COVID-19 vaccines in electronic healthcare databases: a protocol template from the ACCESS project

DARWIN EU® study

No

Study countries

Italy
Netherlands
Spain
United Kingdom

Study description

As part of the preparedness activities for surveillance of COVID-19 vaccines, this template protocol provides a template for quickly developing a full study protocol to perform vaccine coverage studies through the secondary use of electronic healthcare data bases and/or immunization registers. This protocol has been accepted by EMA as a deliverable of the framework contract No EMA/2018/28/PE.

Study status

Finalised
Research institutions and networks

Institutions

Networks

Contact details

Miriam Sturkenboom

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

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

3g.Protocol_ACCESS_CoverageEvaluation

English (1.33 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