Ethics Committee This section shall document that the clinical investigation was conducted in accordance with the ethical principles of Declaration of Helsinki. A detailed description of the Ethics Committee constitution and date(s) of approvals of investigation documents for each of the participating sites should be provided. A declaration shall state that EC notifications as per Good Clinical Practice Guidelines issued by Central Drugs Standard Control Organization and Ethical Guidelines for Biomedical Research on Human Subjects, issued by Indian Council of Medical Research have been followed. The ethics report shall include the following points:— (a) a confirmation that the CIP and any amendments to it were reviewed by the EC; (b) a list of all ECs consulted. 6.4 Clinical investigation team Briefly describe the administrative structure of the clinical investigation (Investigators, site staff, Sponsor/designates, Central laboratory etc.). 7. Results The results should include the following points:— (a) the clinical investigation initiation date; (b) the clinical investigation completion/ suspension date; (c) the disposal of subjects and investigational medical devices; (d) the subject demographics; (e) clinical investigation plan compliance; (f) an analysis, which includes, — (i) a performance analysis as provided in the clinical investigation plan; (ii) a summary of all adverse events and adverse device effects, including a discussion of the severity, treatment needed, resolution and relevant principal investigator's judgment concerning the causal relationship with the investigational medical devices or procedure; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 201 of 248 (iii) a table compiling all observed device deficiencies that could have led to a serious adverse effect, and any corrective actions taken during the clinical investigation, if any; (iv) any needed subgroup analysis for special populations (i.e. gender, racial /cultural /ethnic subgroups), as appropriate; (v) an accountability of all subjects with a description of how missing data or deviation(s) were dealt within the analysis, including subjects:— (A) not passing screening tests; (B) lost to follow-up; (C) withdrawn or discontinued from the clinical investigation and the reason.