Study Network

The VAC4EU study network comprises research organisations (governmental and non-governmental or private), public health institutes, and data access providers under the condition of being qualified and able to provide either access to relevant data and/or relevant expertise to the post-marketing monitoring of vaccines (exposure, coverage, risks, benefits).

Within the study network we distinguish the following roles beyond the general governance bodies of VAC4EU:

  • Study requester: organisation that requests a study to be done, this can be public or private

  • Principal investigator: lead investigator with final responsibility of the study

  • Study network board: board with representative of each of the member organisations in the study network

  • Lead operating Center (LOC): organisation coordinating and contracting the study

  • Study partners: organisations participating in the study

  • Study team: individuals participating in the study

 The VAC4EU study network is responsible for the following key activities

  • Provide information on data sources to allow quick feasibility assessment (meta-data and database characterisation to be uploaded in the fingerprint tool)

  • Conduct vaccine coverage, benefit, risk and benefit/risk studies and monitoring according to VAC4EU endorsed best practice and procedures

 

Data Sources

The VAC4EU members have access to a large variety of electronic health care databases in different EU countries. Electronic health care databases are usually a result of the electronic recording of routine health care and are not developed specifically for research. The structure and content vary within and between European countries. Data may arrive from general practitioners, claims data, vaccine registries, surveillance data, trial data or a combination of those.

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Database characterisation and assessment

In order to characterize the data sources based on actual content of the data and assess whether they were fit for purpose for vaccines studies we developed database characterisation procedures, which was called fingerprinting.  The fingerprinting of input files demonstrated to be a good system for harmonisation and benchmarking and it is crucial to assess feasibility of data sources to participate in network studies on specific questions.

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Decision making and roles in the conduct of studies

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Operations of VAC4EU study network

The VAC4EU study network will use a common protocol across all study sites, a common data model and common analytics according to the model below and follow the ADVANCE or ENCePP Code of Conduct.

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Data sharing & privacy

VAC4EU processes (based on sharing of aggregated anonymised data) are compliant with the EU General Data Protection Regulation (GDPR) and are also following some key new principles.

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