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. 3. Table of contents The table of contents may include the following information:— Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 198 of 248 (a) the page number or locating information of each section, including summary tables, figures, and graphs; (b) a list of appendices and their location. 4. Summary The summary may contain the following items:— (a) the title of the clinical investigation; (b) an introduction; (c) the purpose of the clinical investigation; (d) description of the clinical investigation population; (e) the clinical investigation method used; (f) the results of the clinical investigation; (g) the conclusion; (h) the date of the clinical investigation initiation; (i) the completion date of the clinical investigation or, if the clinical investigation is discontinued, the date of premature termination.