In the Dissemination Phase the evidence is synthesised in reports and result dashboards, and potentially in publications. All study artefacts are then retained 

Evidence Synthesis

The results of all data sources are combined to produce the tables and figures needed for the report in the Digital Research Environment. The amount of effort for Evidence Synthesis will strongly depend on the study complexity, i.e., less effort for the “off-the-shelf” and “routine repeated studies” and more effort for the complex studies. The pooling of database-specific results will be pre-specified per protocol, including rules/diagnostics precluding the inclusion of a database and the use of meta-analytic approaches to combine data-specific estimates. The results are reviewed, and conclusions are formed in the context of the prior knowledge if relevant.

Dashboard Instantiation

In most studies executed against the OMOP-CDM, a large amount of study results is generated from many data sources. Therefore, dashboards in the form of a web application will be made to simplify the exploration of the results. All the uploaded study results can be easily combined in a single folder from which the dashboard is instantiated. The web application will either be made publicly available or if necessary, will be made available behind a security layer.

Reporting of Study Results

The study team then writes the report and/or publication. All study reports are written in accordance with the Guideline on good pharmacovigilance (GVP) module VIII, (EMA/813938/2011) and the guidance from ENCePP. The (final) study report(s) are uploaded in the EU PAS Register.

Study findings will preferably be considered for publication as open access. Any publication will be guided by the Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication of the International Committee of Medical Journal Editors (ICMJE). 


Before closure of the study all generated documents, used analytics, and study results are archived to enable reproducibility.