Vaccine Effectiveness, Burden and Impact Studies (VEBIS) of COVID-19 and Influenza – Tender Specifications OJ/2021/DPR/12924  DL 4.5.1. Protocol for  an additional study  including analysis plan  The contractor is expected to perform additional studies such as validation studies,  additional impact studies or revise substantially the initial agreed study plans to  account for changes in the epidemiology of disease, vaccination programmes and  availability of specific health registries at study site level. The protocol shall include standard operating procedures (SOPs) for recruitment,  data management, data checking and validation, and data analysis, as annexes of  the study protocol. Deliverable includes a statistical analysis plan for a pooled  analysis.  By framework  contract end date  Word – ECDC  template  DL 4.5.2. Interim  report on the  additional study  Interim report. Format to be agreed during monthly teleconferences.  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.  Two times:  foreseen in year 2  and 3  Word - ECDC  template  DL 4.5.3. Final report  on the additional  study  Final report. Format to be agreed during monthly teleconferences. 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.  Cumulative data presented since the beginning of data collection.  One time, foreseen  at the end of the  framework  contract  Word - ECDC  template  Consultancy Services  In addition to the above deliverables, the contractor could be asked to provide ECDC with expertise in the competence areas of surveillance, vaccine  effectiveness, impact including statistical, or any other expertise viewed helpful to ECDC. These profiles would be requested on an ad hoc and/or as  needed basis and would be short term support.  Profile  Description 