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. 5. Introduction The introduction may contain a brief statement placing the clinical investigation in the context of the development of the investigational medical device and relating the critical features of the clinical investigation (e.g. objectives and hypotheses, target population, treatment and follow-up duration) to that development.
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