Template Protocols

VAC4EU was a consortium member of the ACCESS project. One of the outputs of this project was to produce template protocols for vaccine safety, effectiveness and coverage studies. Here you can read and download these protocols.

Template Protocols for Vaccine Safety Studies

ACCESS (vACCine covid-19 monitoring readinESS) was a project led through the EU Pharmacoepidemiology & Pharmacovigilance Network (EU PE & PV) and delivered in December of 2020. The goal of ACCESS was to set up a network for timely monitoring of coverage, safety and effectiveness of COVID-19 vaccines and the investigation of specific research questions, through the contributions of several consortium members including VAC4EU. VAC4EU provided a common infrastructure via a Common Data Model (the ConcePTION CDM), common analytics, and the development of common protocols.

The ACCESS project developed several template protocols for COVID-19 vaccine coverage, safety and effectiveness monitoring. The protocols are also divided into those using primary data collection and those that rely on secondary electronic healthcare data. These templates were prepared at the request of the EMA. In October of 2020, the European Commission recommended that member states and public health authorities prepare to undertake large-scale, EU-wide studies of the effectiveness and safety of COVID-19 vaccines. These template protocols are part of this preparedness activity, as they allow for quickly developing a full, complete study protocol to perform vaccine studies. All template protocols were reviewed by EMA as well as stakeholders.

  Download the Template Protocols

EUPAS38915. Meurs L; Krant A; et al. Cohort event monitoring to assess safety of COVID-19 vaccines using patient reported events, a protocol template from the ACCESS project.
EUPAS39361. Dodd C; Willame C; et al. Rapid assessment of COVID-19 vaccines safety concerns through electronic health records: a protocol template from the ACCESS project.
EUPAS39361. Dodd C; Willame C; et al. Safety evaluation of COVID-19 vaccines in electronic healthcare databases: a protocol template from the ACCESS project.
EUPAS39361. Kawai A; Arana A; et al. Safety Protocol for Hospital Case–Based Monitoring of Specific Adverse Events Following COVID-19 Vaccines: A Protocol Template from the ACCESS project.
EUPAS39289. Díaz-Domingo J; Mira-Iglesias A; Carmona-Serrano A et al. Core protocol for SARS-CoV-2 vaccine effectiveness studies (test-negative design studies) a protocol from the ACCESS project.
EUPAS39289. Layton B; García de Albéniz X et al. Real-world effectiveness of <> in Europe: a protocol template for a cohort study based in existing health care data sources from the ACCESS project.
EUPAS39370. Layton B; García de Albéniz X et al. Coverage of COVID-19 vaccines in electronic healthcare databases: a protocol template from the ACCESS project.