Risks and benefits of the investigational medical device and clinical investigation (a) Anticipated clinical benefits. (b) Anticipated adverse device effects. (c) Residual risks associated with investigational medical device, as identified in the risk analysis report. (d) Risks associated with participation in the clinical investigation. (e) Possible interactions with concomitant medical treatments. (f) Steps that will be taken to control or mitigate the risks. (g) Risk-to-benefit rationale. 1.5 Objectives and hypotheses of the clinical investigation (a) Objectives, primary and secondary. (b) Hypotheses, primary and secondary, to be accepted or rejected by statistical data from the clinical investigation. (c) Claims and intended performance of investigational medical device that are to be verified. (d) Risks and anticipated adverse device effects that are to be assessed. 1.6 Design of the clinical investigation 1.6.1 General Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 183 of 248 (a) Description of the type of clinical investigation to be performed (e.g. comparative double-blind, parallel design, with or without a comparator group) with rationale for the choice. (b) Description of the measures to be taken to minimize or avoid bias, including randomization and blinding or masking. (c) Primary and secondary endpoints, with rationale for their selection and measurement. (d) Methods and timing for assessing, recording, and analyzing variables. (e) Equipment to be used for assessing the clinical investigation variables and arrangements for monitoring maintenance and calibration. (f) Any procedures for replacement of subjects. 1.6.2 Investigational medical device and comparator (a) Description of the exposure to the investigational medical device or comparator, if used. (b) Justification of the choice of comparator. (c) List of any other medical device or medication to be used during clinical investigation. (d) Number of investigational medical devices to be used, together with a justification.