Vaccine Effectiveness, Burden and Impact Studies (VEBIS) of COVID-19 and Influenza – Tender Specifications – Lot 2 OJ/2021/DPR/12924  Deliverable (DL)  Description  Estimated frequency/  Volume  File / form at type  DL 2.6.1. Feasibility  report for an  additional study (e.g.  household  transmission study)  Topic of the feasibility report to be agreed during the monthly conferences with  ECDC.  The feasibility assessment shall be performed describing alternative  methodological approaches to address study objectives, recruitment options, risk  of bias assessment with potential mitigations, and anticipated time for results to  be available. The feasibility assessment should discuss the possibility to recruit the  adequate number of individuals and of generating scientifically sound data within  the project timelines.  Three times during the  duration of the  framework contract, in  year 1 and 2 Word  DL 2.6.2. Protocol  for an additional  study including  analysis plan  Production of a study protocol.  The protocol shall 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. 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.  One time during the  duration of the  framework contract, in  year 1  Word - ECDC  template  DL 2.6.3. Regular  laboratory data  update  Production of regular laboratory results summary table to ECDC specifying the  number of laboratory specimens processed and tested and the proportion of  positive samples by study site, stratified by key variables. This deliverable includes  all costs of sample processing, transport, laboratory data management and the  diagnostic assay and refers to cost of performing the molecular diagnostic and  serology (i.e. RT-PCR) and serology, including standardization.  Format to be agreed during monthly teleconferences; cumulative data presented  since the beginning of data collection, pooled and by study site.  Three times, during  year 1 and 2  Word 