EUMAEUS: Evaluating Use of Methods for Adverse Event Under Surveillance (for vaccines)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43745
• EU PAS number:
  EUPAS40259
• Study ID:
  43745
• Official title and acronym:
  EUMAEUS: Evaluating Use of Methods for Adverse Event Under Surveillance (for vaccines)
• DARWIN EU® study:
  No
• Study countries:
  Netherlands

  United States
• Study status:
  Planned

Research institution and networks

Networks

Observational Health Data Sciences and Informatics (OHDSI) Network

Study timelines

Date when funding contract was signed

Planned: 01/02/2021

Study start date

Planned: 01/03/2021

Date of final study report

Planned: 01/09/2021

Sources of funding

Other

More details on funding

This is an open science study with collaborators from multiple institutions across academia, regulators, and industry

Study protocol

Initial protocol

Protocol_1_0_0 (002)

Updated protocol

EUMAEUS_protocol updated

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable