Status: Finalised First registered on: 19/02/2021
Last updated on: 09/01/2023
1. Study identification
EU PAS Register NumberEUPAS39361
Official titleACCESS template protocol for safety of COVID-19 vaccines
Study title acronymACCESS
Study typeObservational study
Brief description of the studyThis 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
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsUMCU
Department/Research groupJulius Center
Organisation/affiliationUniversity Medical Center Utrecht
Website/Homepagewww.umcutrecht.nl
Details of (Primary) lead investigator
Title Professor
Last name Sturkenboom
First name Miriam
Is this study being carried out with the collaboration of a research network?
Yes

VAC4EU
EU PE&PV research network
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?20

Pharmacol UNIVR
IDIAPJGol
UMCU
Department of Epidemiology Lazio Region, Italy
BIPS GmbH
ARS
PELyon
AEMPS
Unit of Clinical Psychopharmacology - Verona
University of Messina
PHARMO Institute
DSRU
Utrecht University Pharmacoepidemiology Center
Netherlands Pharmacovigilance Centre Lareb
Aarhus University Dept. of Clinical Epidemiology
RTI-HS
Health Search-SIMG
Bordeaux PharmacoEpi
Countries in which this study is being conducted
International study

Belgium
Denmark
France
Italy
Netherlands
Norway
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed21/05/202021/05/2020
Start date of data collection21/05/202021/05/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report15/12/202030/06/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherEMA100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Sturkenboom
First name Miriam
Address line 1Heidelberglaan 100
Address line 2 
Address line 3 
CityUtrecht 
Postcode 
CountryNetherlands
Phone number (incl. country code)31657831983 
Alternative phone number 
Fax number (incl. country code) 
Email address m.c.j.sturkenboom@umcutrecht.nl
Public Enquiries
Title Professor 
Last name Sturkenboom 
First name Miriam 
Address line 1Heidelberglaan 100 
Address line 2 
Address line 3 
CityUtrecht 
Postcode 
CountryNetherlands 
Phone number (incl. country code)31657831983 
Alternative phone number 
Fax number (incl. country code) 
Email address m.c.j.sturkenboom@umcutrecht.nl 
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