CLINICAL INVESTIGATION REPORT 1. General This table specifies the contents of the clinical investigation report that describes the design, execution, statistical analysis and results of a clinical investigation. 2. Cover page The page shall contain the following information:— (a) title of the clinical investigation; (b) identification of the investigational medical devices, including names, models, etc. as relevant for complete identification; (c) if not clear from the title, a single sentence describing the design, comparison, period, usage method, and subject population; (d) name and contact details of sponsor or sponsor's representative; (e) CIP identification/protocol code; (f) name and department of coordinating investigator and names of other relevant parties, e.g. experts, biostatistician, laboratory personnel; (g) statement indicating whether the clinical investigation was performed in accordance with declaration of Helsinki, Good Clinical Practice guidelines and applicable regulations; (h) Brief description of investigation design; (i) Start and end date of patient accrual and names of the sponsor and the participating institutes; (j) author(s) of report.