General (i) Case Report Forms are established to implement the clinical investigation plan, to facilitate subject observation and to record subject and investigational medical device data during the clinical investigation according to the clinical investigation plan. They can exist as printed, optical, or electronic documents and can be organized into a separate section for each subject. (ii) The Case Report Forms should reflect the clinical investigation plan and take account of the nature of the investigational medical device. 2. Content and format Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. 2.1 Overall considerations (i) The Case Report Forms can be organized such that they reflect all the data from a single procedure or a single visit or other grouping that makes clinical or chronological sense. (ii) The format of Case Report Forms shall be such as to minimize errors that can be made by those who enter data and those who transcribe the data into other systems. (iii) The data categories and format listed in this Table can be considered when designing a Case Report Form.