Study governance

Study Principal Investigator is Professor, MD, Ph.d., DMSc. Lars Østergaard, head of the coordinating center Department Infectious Diseases, Aarhus University and Aarhus University Hospital.

Study Sponsor and Data and Statistical Centre is Centre for Health and Infectious Diseases Research (CHIP) Department of Infectious Diseases, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark, under the direction of Professor Jens Lundgren.

The DSC will handle data and sample management, bioinformatic processing, research coordination. Including securing the infrastructure to maintain high validity of data and sample collection, storage, statistical analysis, bioinformatic processing and coordination between the involved academic and government partners.

DSC provides the Danish Medicines Agency (the principle receiving entity) with regular monthly reports in an agreed format. The reports will consist of two principle sections: one on operational implementation and data quality, and one on outcomes. Additional analyses may prompt the review of these reports. These reports are considered confidential except otherwise agreed on by the respective steering committee.

Access to Data

According to the ENFORCE study protocol proposals to study new issues using the ENFORCE data can be made by study investigators and by external investigators. All proposals are reviewed by the ENFORCE Scientific Steering Committee. Only proposals within the purpose of ENFORCE will be reviewed. Proposals that request access to biological material will upon scientific approval be prioritized according to potential relevance for qualifying the national vaccine effort and their utilization of the large number of participants in ENFORCE. Biological materials will only be transferred after 1 May 2022 at the earliest.
Any additional costs related to the sharing of ENFORCE-data must be met by the applicant.

Requirements for applications and the process of valuation can be found here.