Justification for the design of the clinical investigation Justification for the design of clinical investigation, which shall be based on conclusions of the evaluation, and shall comprise a section on justification for the design of the clinical investigation and include— (a) an evaluation of the results of the relevant pre-clinical testing or assessment carried out to justify the use of investigational medical device in human subjects; and (b) an evaluation of clinical data that are relevant to the proposed clinical investigation. 1.4 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.