Vaccine Effectiveness, Burden and Impact Studies (VEBIS) of COVID-19 and Influenza – Tender Specifications OJ/2021/DPR/12924  Deliverable (DL)  Description  Estimated  frequency/ Volume  File / form at type  DL 4.2.1.  Feasibility/Landscape  analysis and report  The preparation of the study will involve to conduct a landscape analysis of  potential study sites in the EU/EEA in order to identify suitable study sites with the  ability to meet study requirements and objectives.  The report will include a clear, detailed and list of possible study sites in light of the  availability of health registries to meet study objectives and the ability to be used  for a vaccine effectiveness study.  In addition, the report will include a full and detailed list and description of the  health registries, including: named focal point, region covered/included in the  registry, and data sources.  Three times: year 1  within 3 months after signature of  the first Specific  Contract; then in  year 2 and 3  Word  DL 4.2.2. Pilot  protocol and pilot  study. The protocol  and associated study  documents will be  pilot tested in a  minimum of 2  countries/study sites  for a period of  maximum 3 months  Based on the results of the feasibility and landscape analysis, the contractor will  prepare a pilot study protocol for vaccine effectiveness and pilot the study. Deliverable includes a study protocol with a statistical analysis plan, conduction of  the pilot study, data analysis, results of the study described in the report as well as  recommendations from the pilot project. The protocol will include a codebook with a minimum set and the full list of  variables to be collected; sample size calculations, questionnaire/s to be  administered, matching algorithm for data originating from multiple health register  and checking for duplicate data.  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.  The contractor is expected to pilot test the protocol, study documents, data  collection flows and analysis in a subset of study site (minimum 2 study  sites/countries) to be agreed with ECDC. Findings from this pilot will inform the  Two times: the first  within 6 months  after the signature  of the first specific  contract, the  second before the  end of the  framework  contract  Word 