Status: Planned First registered on: 19/02/2021
Last updated on: 19/02/2021
1. Study identification
EU PAS Register NumberEUPAS39370
Official titleCoverage of COVID-19 vaccines in electronic healthcare databases: a protocol template from the ACCESS project
Study title acronymACCESS
Study typeObservational study
Brief description of the studyAs 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.
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 group
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

EU PE&PV research network
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Italy
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed19/05/202019/05/2020
Start date of data collection19/05/2020
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 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) 
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) 
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