Vaccine Effectiveness, Burden and Impact Studies (VEBIS) of COVID-19 and Influenza – Tender Specifications – Lot 2 OJ/2021/DPR/12924  Task 5: Evaluation of the study  The contractor is expected to perform validation studies expanding on the main study. The studies might be conducted in a representative sample from  each study site. In addition, the contractor will be responsible for planning and verifying the quality and validity of the data through the performance of  regular quality control checks including providing a check list for the study sites.  Deliverable (DL)  Description  Estimated frequency/  Volume  File / form at type  DL 2.5.1. Validation  study  A data validation study might be conducted in a representative sample in each  study site. The data validation study includes a protocol, the study implementation  and the report of the study. 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. The report will include: a summary, aim, general background, objectives, methods,  description of data analysis, summary of findings, discussion, conclusion,  recommendations on future studies, references, annexes.  By the end of the  framework contract  Word – ECDC  template DL 2.5.2. Evaluation  of study site/hospital  study specific  implementation  The contractor will be responsible for planning and verifying the quality and  validity of the data through the performance of regular quality control checks.  The deliverable includes a protocol, data collection, datasets and a report including  results and recommendations.  By specific contract  end date  Word  Task 6: Additional vaccine effectiveness study (e.g. transmission study)  The contractor shall perform additional studies to be built on the main study population of healthcare workers. Studies on effectiveness of COVID-19  vaccines against SARS-CoV-2 transmission could be requested involving, but not limited to, healthcare workers’ household studies. 