Summary evaluation of serious adverse events (SAEs) Please convert the "summary evaluation“ template into PDF to ensure write protection, but leave the attached documents/table in the original format, do not change them to PDF. Master data Administrative Informationen / administrative information Date (day, month, year)* Date of the last "SAE summary evaluation"* Date of the last "SAE summary report" (quarterly reviewed)* (MEDDEV 2.7/3 SAE Report Table) Data on clinical investigation (KP), performance evaluations (LP): Title of KP, LP* Sponsor´s name * Manufacturer´s name* representative Name of sponsor's EEA) (EU, (please indicate, if available) device* Investigational Name, product ID, version device, procedure Comparator Name, product ID, version (Please indicate, if available) Start of KP, LP (First Patient In)* recruiting status in Germany outside Germany Present * number of patients already recuited number of patients aimed at (total) Follow-up status ( e.g. week, month), number of patients* Study already unblinded (yes / no) (please indicate, if applicable) Planned end of KP, LP* * Mantadory field
Summary evaluation of serious adverse events (SAEs) Please convert the "summary evaluation“ template into PDF to ensure write protection, but leave the attached documents/table in the original format, do not change them to PDF. Master data Administrative Informationen / administrative information Date (day, month, year)* Date of the last "SAE summary evaluation"* Date of the last "SAE summary report" (quarterly reviewed)* (MEDDEV 2.7/3 SAE Report Table) Data on clinical investigation (KP), performance evaluations (LP): Title of KP, LP* Sponsor´s name * Manufacturer´s name* Name of sponsor's representative (EU, EEA) (please indicate, if available) Investigational device* Name, product ID, version Comparator device, procedure Name, product ID, version (Please indicate, if available) Start of KP, LP (First Patient In)* Present recruiting status * in Germany outside Germany number of patients already recuited number of patients aimed at (total) Follow-up status ( e.g. week, month), number of patients* Study already unblinded (yes / no) (please indicate, if applicable) Planned end of KP, LP* * Mantadory field