Status: Planned First registered on: 23/03/2021
Last updated on: 18/10/2021
1. Study identification
EU PAS Register NumberEUPAS40259
Official titleEUMAEUS: Evaluating Use of Methods for Adverse Event Under Surveillance (for vaccines)
Study title acronymEUMAEUS
Study typeObservational study
Brief description of the study
Was this study requested by a regulator?No
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 nameNA
Centre locationNA
Details of (Primary) lead investigator
Title Dr
Last name Schuemie
First name Martijn J
Is this study being carried out with the collaboration of a research network?
Yes
OHDSI
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Netherlands
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/02/2021
Start date of data collection01/03/2021
Start date of data analysis
Date of interim report, if expected
Date of final study report01/09/2021
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
OtherThis is an open science study with collaborators from multiple institutions across academia, regulators, and industry100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Schuemie
First name Martijn J
Address line 1Observational Data Health Analytics
Address line 2Janssen Research and Development 
Address line 3NJ 
CityTitusville 
Postcode 
CountryUnited States
Phone number (incl. country code)310631793897 
Alternative phone number 
Fax number (incl. country code) 
Email address schuemie@ohdsi.org
Public Enquiries
Title Dr 
Last name Schuemie 
First name Martijn J 
Address line 1Observational Data Health Analytics 
Address line 2Janssen Research and Development 
Address line 3NJ 
CityTitusville 
Postcode 
CountryUnited States 
Phone number (incl. country code)310631793897 
Alternative phone number 
Fax number (incl. country code) 
Email address schuemie@ohdsi.org 
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