Vaccine Effectiveness, Burden and Impact Studies (VEBIS) of COVID-19 and Influenza – Tender Specifications ECDC/2021/12924  Task 7: Additional studies  Over the course of the project the contractor will perform additional studies which may derive from additional sources of data than those collected routinely  within the ECDC Hospital network. Such studies can include studies to validate the results obtained through the routine SARI surveillance/vaccine  effectiveness studies, burden of disease or impact studies. Deliverable (DL)  Description  Estimated  frequency/ Volume  File / form at type  DL 1.7.1. Protocol for  additional studies within  the ECDC hospital  network (such as Impact  studies, Validation  studies, Sensitivity  studies, Burden of  disease studies)  Protocol for additional studies within the ECDC hospital network. The protocol should include background, objectives, assumptions, description  of data sources/countries which will be included in the additional study, the  methodology and plan of analysis, sample size calculations, a detailed  description of the variables to be collected and their coding, challenges,  limitations, references, annexes. In addition, the protocol will include the  statistical analysis plan and the procedures needed at study site level to  implement the study.  Six units, foreseen  in year 2, 3 and 4  Word – ECDC  template  DL 1.7.2. Interim report  on the additional study  Interim report. Format to be agreed during monthly teleconferences.  Interim report on one of the additional studies, based on implementation of  the protocol. Cumulative data presented since the beginning of data collection. The interim report will include: a summary, aim, general background,  objectives, methods, description of preliminary data analysis, summary of  preliminary findings, discussion, conclusion, recommendations on how to  further continue with the implementation of the study, references, annexes.  6 units, foreseen in  year 2, 3 and 4 Word - ECDC  template 