Vaccine Effectiveness, Burden and Impact Studies (VEBIS) of COVID-19 and Influenza – Tender Specifications OJ/2021/DPR/12924  DL 5.4.1. EU/EEA  protocol for integrated  vaccine effectiveness  (VE) studies against  seasonal influenza and  COVID-19 among  outpatients An EU/EEA study protocol to assess VE for both COVID-19 and seasonal influenza  in an integrated network shall be developed and updated on an annual basis if  requested.  The protocol may be based on adaptations of previous protocols, which will be  shared by ECDC. 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.  Deliverable includes a statistical analysis plan for a pooled analysis. The protocol  will include a detailed description of all testing and laboratory components  included in the study and type of frequency 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.  Once a year  Word - ECDC template  DL 5.4.2. Draft or  update country- and  site-specific Standard  Operating Procedures  to implement EU/EEA  protocols  For operational implementation, country (or site) specific Standard Operating  Procedures shall be drafted and updated on an annual basis if requested.  The protocols will be in the respective national language(s) of the countries,  unless otherwise agreed with the countries (to be documented and sent to  ECDC), with an English summary.  Dependent on new  countries/study  sites Word  DL 5.4.3. Develop  technical documents  related to COVID-19  vaccine effectiveness  among outpatients  (such as TESSy  reporting protocol,  TESSy metadata,  definitions) The deliverable refers to methodological work performed at coordination level. The updates are foreseen as a regular and constant activity through the course of  the project, with the deliverable being formally produced at the indicated  frequency. These are specific updates to be undertaken in agreement with ECDC and may  include methodological items/aspects such as TESSy reporting protocol, TESSy  metadata, and definitions.  Twice a year  Word – ECDC template 