Vaccine Effectiveness, Burden and Impact Studies (VEBIS) of COVID-19 and Influenza – Tender Specifications OJ/2021/DPR/12924  countries/study sites,  with standard  template across sites  COVID-19 vaccination campaign, and other ongoing or planned studies on COVID-19  at the same study site. DL 4.2.6.  Country/study site  specific protocol and  Standard Operating  Procedures to  implement the  EU/EEA protocol. Country specific protocols for countries joining the vaccine effectiveness studies.  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.  One time per  study, dependent  on number of  countries Word  DL 4.2.7. Technical  documents related to  data collection such as  reporting protocol,  metadata, and  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 updates to be undertaken in agreement with ECDC and may include  methodological items/aspects such as TESSy reporting protocol, TESSy metadata,  and definitions or a reporting protocol, metadata and definitions. Twice a year  Word and format  compatible with  statistical software  (e.g. STATA, R, csv)  DL 4.2.8. Validated  datasets and  production of regular  epidemiological data  summary/report.  Collection (as needed) and validation of dataset. This is foreseen as a regular and  constant activity through the course of the project.  Deliverable includes scripts, datasets and epidemiological data summary. Format to  be agreed during monthly teleconferences. The validation of the datasets will be performed in close collaboration with the  countries/study sites and will be aimed to build capacity and foster a progressive  improvement of data reported by the countries/study sites over the course of the  framework contract. Communication between the contractor and the  countries/sites to validate the data will take place using principles agreed between  the contractor and ECDC and periodically revisited.  The contractor is expected to supervise and coordinate the data collection from the  study sites and to work closely with ECDC to establish a data flow from the countries  to ECDC. Therefore the contractor is expected to support the implementation of the  studies with the collection (as needed) and validation of the datasets from the  Biweekly, after  starting data  collection  Word and format  compatible with  statistical software  (e.g. STATA, R, csv) 