Report on Quality control

A report on quality control and safety is given with regards to the trial An update is foreseen to be given at the end of the project D55 The following tasks will be checked and implementedo Appointment of NICI Clinical Trial Manager NICI Data Manager and local Clinical Study TeamsoStart of study preparation by ICI Clinical Trial Manager NICI Data Manager and local Clinical Study TeamsoStudy documents information sheets and informed consent forms prepared and internally approvedoStudy protocols finalisedoprocedure for international monitoring finalisedoEthical approval granted for study and monitoring protocol at all clinical sitesoNICI Data collection and processing infrastructure ready for useoAll clinical sites fully equipped and ready to start patient inclusionReport on quality controloFirst Patient or study subject First Visit FPFVoLast Patient or study subject First Visit LPFVoLast Patient or study subject Last Visit for primary analysis LPLVoPrimary end of Study EXCLUDING followup and data analysis note in case of positive endpoint participated institutes are entitles to incorporate more patients using alternative sources of funding