Study identification

EU PAS number

EUPAS39361

Study ID

50436

Official title and acronym

ACCESS template protocol for safety of COVID-19 vaccines

DARWIN EU® study

No

Study countries

Belgium
Denmark
France
Italy
Netherlands
Norway
Spain
United Kingdom

Study description

This listing includes the four different safety protocol templates to monitor COVID-19 vaccine safety. These protocols were prepared on request of EMA and have been reviewed by EMA and stakeholders. Protocols require finalization by the final users and are not conducted as such. This registration includes the following protocols: 1. Cohort event monitoring to assess safety of COVID-19 vaccines using patient reported events, a protocol template from the ACCESS project 2. Rapid assessment of COVID-19 vaccines safety concerns through electronic health records: a protocol template from the ACCESS project 3. Safety evaluation of COVID-19 vaccines through electronic health records: a protocol template from the ACCESS project 4. Safety Protocol for Hospital Case–Based Monitoring of Specific Adverse Events Following COVID-19 Vaccines: A Protocol Template from the ACCESS project Section 19 includes the template protocols. Word documents can be retrieved from study authors or PI. Section 19 includes the final ACCESS report with feasibility assessment

Study status

Finalised
Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
Institution Not-for-profit ENCePP partner
Multiple centres: 20 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:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable