ACCESS template protocol for safety of COVID-19 vaccines

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50436
• 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

University Medical Center Utrecht (UMCU)

Netherlands

Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

Netherlands

Health Search, Italian College of General Practicioners

Italy

Unit of Clinical Psychopharmacology and Drug Epidemiology, University of Verona

Italy

Netherlands Pharmacovigilance Centre Lareb

Netherlands

PharmacoEpidemiology Unit (PELyon), Claude Bernard Lyon 1 University

France

Department of Epidemiology of the Regional Health Service - Lazio

Italy

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

Drug Safety Research Unit (DSRU)

United Kingdom

University Medical Center Utrecht (UMCU)

Netherlands

Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina

Italy

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Pharmacology Unit - Veneto Pharmacovigilance Centre (Pharmacol UNIVR), University Hospital Verona

Italy

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

Bordeaux PharmacoEpi, University of Bordeaux

France

Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency for Medicines and Medical Devices, AEMPS)

Spain

Multiple centres: 20 centres are involved in the study

Networks

Vaccine monitoring Collaboration for Europe (VAC4EU)

Belgium

Denmark

Finland

France

Germany

Italy

Netherlands

Norway

Spain

United Kingdom

EU Pharmacoepidemiology and Pharmacovigilance (PE&PV) Research Network

Netherlands

Study timelines

Date when funding contract was signed

Planned: 21/05/2020

Actual: 21/05/2020

Study start date

Planned: 21/05/2020

Actual: 21/05/2020

Date of final study report

Planned: 15/12/2020

Actual: 30/06/2021

Sources of funding

EMA

Study protocol

Initial protocol

3c.Protocol_ACCESS_Safety-Evaluation-EHR

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable