Vaccine Effectiveness, Burden and Impact Studies (VEBIS) of COVID-19 and Influenza – Tender Specifications – Lot 2 OJ/2021/DPR/12924  Task 2: Preparation and implementation of a vaccine effectiveness study in a cohort of healthcare workers  The contractor is expected to perform all preparatory work needed to set up the study in coordination with ECDC and implement a vaccine effectiveness  study in a cohort of healthcare workers. Deliverable (DL)  Description  Estimated frequency/  Volume  File / form at type  DL 2.2.1. Update of  EU/EEA Protocol for  a study on vaccine  effectiveness among  health care workers  The protocol should include: a detailed description of the study design; a study  participants recruitment plan; a list of all study outcomes and variables of interest;  all testing and laboratory components to be included in the study, type and  frequency of sampling; a codebook with a minimum set and the full list of variables  to be collected; sample size calculations; questionnaire/s to be administered to the  study participants; and a statistical analysis plan for a pooled analysis.  The protocol will include standard operating procedures (SOPs) for: recruitment of  study participants, data management, data checking and validation, reporting and  data transfers, and data analysis, as annexes of the study protocol.  One time during the  duration of the  framework contract  Word – ECDC  template  DL 2.2.2. Proposed  list of sites joining  the study  The contractor will assess the feasibility of study sites to join the study, based on an  initial list provided by ECDC which may be further expanded. The preparation to the  study will involve the support in the identification and recruitment of study sites. The contractor will identify suitable study sites (hospital/units) for performing the  study in agreement with ECDC. ECDC will facilitate the identification of the study  sites through national authorities. The following aspects shall be considered by the contractor when assessing the  feasibility  • The identified sites shall be able to implement the protocol(s); it is expected  that contractor will ensure that the study sites identify data flows which will  allow capturing information on SARS-CoV variants (such as whole genome  sequencing) and capture the information as part of the data collection.  Identification of the variants could either be undertaken at the study  site/national level in collaboration with the relevant national Authorities, or  Twice during the  duration of the  framework contract  Word 