Status: Planned First registered on: 10/01/2021
Last updated on: 10/01/2021
1. Study identification
EU PAS Register NumberEUPAS38915
Official titleSafety of COVID-19 vaccines: template protocol from the ACCESS project on cohort event monitoring
Study title acronymACCESS
Study typeObservational study
Brief description of the studyThis listing includes one of 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 1) Cohort event monitoring study for safety monitoring/signal detection, prepared by LAREB Section 17 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)not applicable this is a study template from the ACCESS project
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsNetherlands Pharmacovigilance Centre Lareb
Department/Research group
Organisation/affiliationNetherlands Pharmacovigilance Centre Lareb
Website/Homepagewww.lareb.nl
Details of (Primary) lead investigator
Title Professor
Last name van Puijenbroek
First name Eugene
Is this study being carried out with the collaboration of a research network?
Yes

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

In total how many centres are involved in this Study?7

Pharmacol UNIVR
Unit of Clinical Psychopharmacology - Verona
UMCU
Utrecht University Pharmacoepidemiology Center
Netherlands Pharmacovigilance Centre Lareb
Phv Department -HALMED
Bordeaux PharmacoEpi
Countries in which this study is being conducted
International study

Belgium
Croatia
France
Germany
Italy
Luxembourg
Netherlands
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed21/05/2020
Start date of data collection21/05/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report15/12/2020
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 van Puijenbroek
First name Eugene
Address line 1Goudsbloemvallei 7
Address line 2 
Address line 3 
City's-Hertogenbosch 
Postcode5237MH 
CountryNetherlands
Phone number (incl. country code)31-73-6469700 
Alternative phone number 
Fax number (incl. country code)31-73-6426136 
Email address e.vanpuijenbroek@lareb.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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